Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Evaluate Quality of Life (QoL) by using the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire at start and during course of vorasidenib treatment

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.

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity

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

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: event rate of seizures

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

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness

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

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures

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

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures with loss of consciousness

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

Time frame: baseline, up to 72 months

Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures

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

Time frame: max. 72 months; from patient-specific study start to end of study (during vorasidenib treatment and follow-up)

Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures with loss of consciousness

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

Time frame: baseline, up to 72 months

Assess effectiveness in routine treatment: Progression-free survival

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.

Time frame: baseline, up to 72 months

Assess effectiveness in routine treatment: Overall Survival (OS)

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.

Time frame: baseline, up to 72 months

Assess effectiveness in routine treatment: Objective response rate (ORR)

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

Time frame: max. 72 months; from patient-specific study start to end of study (during vorasidenib treatment and follow-up)

Assess effectiveness in routine treatment: Disease Control Rate (DCR)

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

Time frame: baseline, up to 72 months

Assess effectiveness in routine treatment: Best response

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

Time frame: baseline, up to 72 months

Assess effectiveness in routine treatment: Time to next intervention (TTNI)

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.

Time frame: baseline, up to 72 months

Assess drug safety: Incidence of (serious) adverse events ((S)AEs)

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

Time frame: Baseline up to 30 days after vorasidenib treatment

Assess drug safety: Incidence of (serious) adverse drug reactions ((S)ADRs)

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

Time frame: Baseline up to 30 days after vorasidenib treatment

Assess drug safety: Incidence of seizures reported as treatment-emergent adverse events (TEAEs)

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.

Time frame: Baseline up to 30 days after vorasidenib treatment

Assess parameters of physicians' treatment decision making using a questionnaire

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

Time frame: Baseline

Duration of treatment with vorasidenib

Describe treatment reality in detail: Duration of treatment with vorasidenib

Time frame: baseline, up to 72 months

Frequency of treatment modifications with reasons

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

Time frame: baseline, up to 72 months

Time to start of vorasidenib treatment after initial diagnosis

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

Time frame: Baseline

Time to start of vorasidenib treatment after surgery

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

Time frame: Baseline

Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)

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

Time frame: baseline, up to 72 months

Anti-epileptic medication: Proportion of patients with anti-epileptic drug (AED) treatment at baseline

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

Time frame: baseline, up to 72 months

Anti-epileptic medication: Proportion of patients with AED treatment during treatment

Proportion of patients with anti-epileptic drug treatment during treatment

Time frame: baseline, up to 72 months

Anti-epileptic medication: Type of AED

Anti-epileptic medication during course of treatment

Time frame: baseline, up to 72 months

Anti-epileptic medication: Doses of AED

Doses of anti-epileptic medication over the course of time

Time frame: baseline, up to 72 months

Anti-epileptic medication: AED modifications

Type of anti-epileptic medication modifications

Time frame: baseline, up to 72 months

Anti-epileptic medication: Reasons for AED modifications

Anti-epileptic medication modifications with reasons thereof

Time frame: baseline, up to 72 months

Anti-epileptic medication: Frequency of patients under AED treatment after End of Treatment (EOT) of vorasidenib

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

Time frame: from end of treatment to end of study, up to 72 months