Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Evaluate QoL by the FACT-Br questionnaire over the course of treatment. Change from baseline in the FACT-Br total score over time. The FACT-Br total score ranges from 0 to 200, with higher scores indicating better quality of life.

Evaluate QoL by using the FACT-Br questionnaire at start and during course of vorasidenib treatment. Change from baseline over time for all other scales of the FACT-Br. For all scales, the higher the score the better quality of life.

Proportion of patients with baseline seizure activity is defined as at least 1 seizure in the previous 30 days prior to vorasidenib treatment start

Exposure adjusted event rate of seizures according to patient-reported outcome (patient diary)

Exposure adjusted event rate of seizures with loss of consciousness according to PRO (patient diary)

Exposure adjusted incidence rate of seizures according to patient-recorded outcome

Exposure adjusted incidence rate of seizures according to patient-reported outcome

Change from baseline of seizures reported by the patients during course of treatment

Change from baseline of seizures with loss of consciousness reported by the patients during course of treatment

PFS ist defined as time interval measured from the day of first vorasidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.

OS is defined as the time interval measured form the day of first vorasidenib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.

ORR is defined as the proportion of patients achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) as best response.

DCR is defined as proportion of patients with Complete Response, Partial Response, Minor Response or Stable Disease as best response.

Best response is defined as Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease (PD))

Time to next intervention is defined as time from first administration of vorasidenib until initiation of next intervention (i.e., subsequent antineoplastic treatment, surgery, chemotherapy or radiotherapy) or death, whichever comes first.

Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.

Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.

Treatment-emergent adverse events (TEAE) are adverse events that were not present before medical treatment, or a pre-existing event that worsens in intensity or frequency during vorasidenib treatment and the following 30 days.

Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.

Describe treatment reality in detail: Duration of treatment with vorasidenib

Describe treatment reality in detail: Frequency of treatment modifications with reasons

Describe treatment reality in detail: Time to start of vorasidenib treatment after initial diagnosis

Describe treatment reality in detail: Time to start of vorasidenib treatment after surgery

Describe treatment reality in detail: Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)

Proportion of patients with anti-epileptic drug treatment at baseline (i.e. 30 days prior treatment)

Proportion of patients with anti-epileptic drug treatment during treatment

Anti-epileptic medication during course of treatment

Doses of anti-epileptic medication over the course of time

Type of anti-epileptic medication modifications

Anti-epileptic medication modifications with reasons thereof

Frequency of patients under AED treatment after EOT of vorasidenib (incl. dose)