Trial Outcomes & Findings for Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) (NCT NCT04164901)

NCT ID: NCT04164901

Last Updated: 2025-04-03

Results Overview

PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 331 participants
• Primary outcome timeframe: Up to approximately 30 months
• Results posted on: 2025-04-03

Participant Flow

Participant milestones

Measure	Vorasidenib Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Overall Study STARTED	168	163
Overall Study COMPLETED	164	159
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Vorasidenib Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

Data was not available

Baseline characteristics by cohort

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets	Total n=331 Participants Total of all reporting groups
Age, Continuous	40.9 years STANDARD_DEVIATION 10.51 • n=168 Participants	39.8 years STANDARD_DEVIATION 9.53 • n=163 Participants	40.4 years STANDARD_DEVIATION 10.04 • n=331 Participants
Age, Customized Participant Age · 12 to less than 16 years old	0 Participants n=168 Participants	0 Participants n=163 Participants	0 Participants n=331 Participants
Age, Customized Participant Age · 16 to less than 18 years old	0 Participants n=168 Participants	1 Participants n=163 Participants	1 Participants n=331 Participants
Age, Customized Participant Age · 18 to less than 40 years old	76 Participants n=168 Participants	87 Participants n=163 Participants	163 Participants n=331 Participants
Age, Customized Participant Age · 40 to less than 65 years old	90 Participants n=168 Participants	74 Participants n=163 Participants	164 Participants n=331 Participants
Age, Customized Participant Age · 65 years or older	2 Participants n=168 Participants	1 Participants n=163 Participants	3 Participants n=331 Participants
Sex: Female, Male Female	67 Participants n=168 Participants	77 Participants n=163 Participants	144 Participants n=331 Participants
Sex: Female, Male Male	101 Participants n=168 Participants	86 Participants n=163 Participants	187 Participants n=331 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=168 Participants	9 Participants n=163 Participants	18 Participants n=331 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	122 Participants n=168 Participants	135 Participants n=163 Participants	257 Participants n=331 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	37 Participants n=168 Participants	19 Participants n=163 Participants	56 Participants n=331 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=168 Participants	0 Participants n=163 Participants	1 Participants n=331 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=168 Participants	8 Participants n=163 Participants	13 Participants n=331 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=168 Participants	1 Participants n=163 Participants	3 Participants n=331 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=168 Participants	0 Participants n=163 Participants	0 Participants n=331 Participants
Race/Ethnicity, Customized Race · White	125 Participants n=168 Participants	132 Participants n=163 Participants	257 Participants n=331 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=168 Participants	1 Participants n=163 Participants	3 Participants n=331 Participants
Race/Ethnicity, Customized Race · Not reported	33 Participants n=168 Participants	21 Participants n=163 Participants	54 Participants n=331 Participants
Region of Enrollment Canada	9 participants n=168 Participants	7 participants n=163 Participants	16 participants n=331 Participants
Region of Enrollment Netherlands	5 participants n=168 Participants	5 participants n=163 Participants	10 participants n=331 Participants
Region of Enrollment United States	77 participants n=168 Participants	100 participants n=163 Participants	177 participants n=331 Participants
Region of Enrollment Italy	4 participants n=168 Participants	6 participants n=163 Participants	10 participants n=331 Participants
Region of Enrollment United Kingdom	7 participants n=168 Participants	10 participants n=163 Participants	17 participants n=331 Participants
Region of Enrollment Israel	25 participants n=168 Participants	16 participants n=163 Participants	41 participants n=331 Participants
Region of Enrollment France	20 participants n=168 Participants	12 participants n=163 Participants	32 participants n=331 Participants
Region of Enrollment Switzerland	8 participants n=168 Participants	1 participants n=163 Participants	9 participants n=331 Participants
Region of Enrollment Germany	7 participants n=168 Participants	2 participants n=163 Participants	9 participants n=331 Participants
Region of Enrollment Spain	6 participants n=168 Participants	4 participants n=163 Participants	10 participants n=331 Participants
BMI (kg/m^2)	26.81 kg/m^2 STANDARD_DEVIATION 5.748 • n=166 Participants • Data was not available	26.52 kg/m^2 STANDARD_DEVIATION 5.887 • n=162 Participants • Data was not available	26.66 kg/m^2 STANDARD_DEVIATION 5.810 • n=328 Participants • Data was not available

PRIMARY outcome

Timeframe: Up to approximately 30 months

PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Progression-Free Survival (PFS)	27.7 months Interval 17.0 to Data was not estimable (median survival time exceeds the longest observed or censored survival time as of the data cut-off date)	11.1 months Interval 11.0 to 13.7

SECONDARY outcome

Timeframe: Up to approximately 3 years

TTNI is defined as the time from randomization to the initiation of the first subsequent anticancer therapy (including vorasidenib, for subjects randomized to placebo who subsequently cross over) or death due to any cause.

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Time to Next Intervention (TTNI)	NA months Data was not estimable (median survival time exceeds the longest observed or censored survival time as of the data cut-off date)	17.8 months Interval 15.0 to Data was not estimable (median survival time exceeds the longest observed or censored survival time as of the data cut-off date)

SECONDARY outcome

Timeframe: every 6 months, up to 2 years and 9 months

Calculated as the mean of the percentage change in tumor volume every 6 months

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Tumor Growth Rate (TGR)	-2.5 percent change Interval -4.7 to -0.2	13.9 percent change Interval 11.1 to 16.8

SECONDARY outcome

Timeframe: approximatively 30 months

OR is defined as a best overall response (BOR) of Complete Response, Partial Rresponse, or minor Response as assessed by the BIRC per the modified Response Assessment in Neuro-oncology for Low-grade Gliomas (RANO-LGG).

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC)	18 Participants	4 Participants

SECONDARY outcome

Timeframe: Approximatively 30 months

CR and PR is defined as a BOR of CR or PR as assessed by BIRC per the modified RANO-LGG

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Complete Response (CR) and Partial Response (PR) by BIRC	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximatively 30 months

Population: The number of participants with CR, PR or mR was 18 and 4, respectively in the vorasidenib and placebo groups. The median time duration of response is analysed only on participants with response.

TTR is defined as the time from the date of randomization to the date of first documented CR, PR, or mR by BIRC per the modified RANO-LGG

Outcome measures

Measure	Vorasidenib n=18 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=4 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Time to Response (TTR) by BIRC	11.0 months Interval 6.0 to 13.4	6.9 months Interval 4.1 to 9.7

SECONDARY outcome

Timeframe: Approximatively 30 months

Population: The number of participants with CR or PR was 2 and 0, respectively in the vorasidenib and placebo groups. The median time duration of response is analysed only on participants with response.

Time to CR+PR is defined as defined as the time from the date of randomization to the date of first documented CR or PR for subjects with CR or PR per the modified RANO-LGG (by BIRC)

Outcome measures

Measure	Vorasidenib n=2 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Time to CR+PR by BIRC	9.6 months Interval 5.6 to 13.6	—

SECONDARY outcome

Timeframe: Approximatively 30 months

DoR is defined as the time from the date of first documented CR, PR, or mR to the date of death due to any cause or date of first documented radiographic Prgressive Disease, whichever occurred earlier

Outcome measures

Measure	Vorasidenib n=18 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=4 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Duration of Response (DoR)	16.6 months Interval 2.8 to 16.6	NA months The median and confidence interval were estimated from Kaplan- Meier method. They were not estimable as very few participants experienced the event.

SECONDARY outcome

Timeframe: Approximatively 30 months

Population: The number of participants with CR or PR was 2 and 0, respectively in the vorasidenib and placebo groups. In the placebo group, no participants experienced the event.

Duration of CR+PR is defined as the time from the date of first documented CR or PR to the date of death due to any cause or first documented radiographic PD, whichever occurred earlier

Outcome measures

Measure	Vorasidenib n=2 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Duration of CR+PR	13.8 months The median and confidence interval were estimated from Kaplan- Meier method. The confidence limits were not estimable as very few participants experienced the event.	—

SECONDARY outcome

Timeframe: Approximatively 30 months

Population: This is based off of the participants in the Safety Set, which includes all subjects that received one least one dose of treatment. The months of survival represent the time between randomization and the data cutoff point, since during the study there were no deaths.

OS wad defined as the time from the date of randomization to the date of death due to any cause or data cutoff.

Outcome measures

Measure	Vorasidenib n=167 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Overall Survival (OS)	NA months Not estimable since there were no deaths during the study	NA months Not estimable since there were no deaths during the study

SECONDARY outcome

Timeframe: Approximatively 30 months

PFS as assessed by the Investigator per the modified RANO-LGG

Outcome measures

Measure	Vorasidenib n=168 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=163 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Progression-Free Survival (PFS) by the Investigator	NA months Interval 27.1 to Data was not estimable (median survival time exceeds the longest observed or censored survival time as of the data cut-off date)	14.1 months Interval 11.2 to 18.5

SECONDARY outcome

Timeframe: Approximatively 30 months

Population: The low number of participants is related to the measure performed at the end of treatment.

Health-Related Quality of Life (HRQoL) Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 50-item measure comprising the following subscales: Physical Well-Being, Functional Well-Being, Emotional Well-Being, and Social Well-Being subscales from the FACT-General (FACT-G), with the addition of a 23-item brain tumor-specific subscale. These subscales are summed to provide a total score. The total score is given at the end of treatment and total scores range from 0 to 200. Higher scores indicate a better HRQoL

Outcome measures

Measure	Vorasidenib n=21 Participants Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets	Matching Placebo n=47 Participants Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets
Health-Related Quality of Life (FACT-Br)	150.8 units on a scale Standard Deviation 29.5	151.8 units on a scale Standard Deviation 31.09

Adverse Events

Vorasidenib

Serious events: 11 serious events

Other events: 158 other events

Deaths: 0 deaths

Matching Placebo

Serious events: 8 serious events

Other events: 152 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vorasidenib n=167 participants at risk Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets One subject in the vorasidenib arm withdrew consent prior to treatment and did not receive the study drug; as a consequence the number of subjects in this group is 167	Matching Placebo n=163 participants at risk Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets The data reflects the subjects assigned to placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, which was an option after the study was unblinded.
Nervous system disorders Seizure	3.0% 5/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	1.8% 3/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Encephalopathy	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Epilepsy	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Partial seizures	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Toxic encephalopathy	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Hepatobiliary disorders Autoimmune hepatitis	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Hepatobiliary disorders Hepatic failure	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Infections and infestations Enterocolitis infectious	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Infections and infestations Postprocedural infection	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Investigations Alanine immunotransferase increased	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.60% 1/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.00% 0/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Psychiatric disorders Suicidal ideation	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	1.2% 2/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Cardiac disorders Myocardial ischemia	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Vascular disorders Hematoma	0.00% 0/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	0.61% 1/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.

Other adverse events

Measure	Vorasidenib n=167 participants at risk Vorasidenib 40 mg, continuous daily dosing. Vorasidenib: Vorasidenib oral film-coated tablets One subject in the vorasidenib arm withdrew consent prior to treatment and did not receive the study drug; as a consequence the number of subjects in this group is 167	Matching Placebo n=163 participants at risk Matching placebo 40 mg, continuous daily dosing. Matching Placebo: Matching Placebo oral tablets The data reflects the subjects assigned to placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, which was an option after the study was unblinded.
Nervous system disorders Headache	26.9% 45/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	27.0% 44/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Dizziness	15.0% 25/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	16.0% 26/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Seizure	10.8% 18/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	9.8% 16/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Nervous system disorders Paraesthesia	6.6% 11/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	6.1% 10/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Gastrointestinal disorders Diarrhoea	24.6% 41/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	16.6% 27/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Gastrointestinal disorders Nausea	21.6% 36/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	22.7% 37/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Gastrointestinal disorders Constipation	12.6% 21/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	12.3% 20/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Gastrointestinal disorders Abdominal Pain	8.4% 14/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	8.6% 14/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Gastrointestinal disorders Vomiting	6.6% 11/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	9.8% 16/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Investigations Alanine aminotransferase increased	38.3% 64/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	14.7% 24/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Investigations Aspartate aminotransferase increased	28.7% 48/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	8.0% 13/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Investigations Gamma-glutamyltransferase increased	15.6% 26/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	4.9% 8/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Infections and infestations COVID-19	32.9% 55/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	28.8% 47/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
General disorders Fatigue	32.3% 54/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	31.9% 52/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
General disorders Asthenia	5.4% 9/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	3.7% 6/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 15/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	9.2% 15/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Musculoskeletal and connective tissue disorders Myalgia	7.2% 12/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	6.1% 10/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Musculoskeletal and connective tissue disorders Back Pain	6.0% 10/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	5.5% 9/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Metabolism and nutrition disorders Hyperglycaemia	9.6% 16/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	4.3% 7/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Metabolism and nutrition disorders Decreased appetite	9.0% 15/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	3.7% 6/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Metabolism and nutrition disorders Hypophosphataemia	7.8% 13/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	4.9% 8/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Psychiatric disorders Insomnia	9.6% 16/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	8.0% 13/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Psychiatric disorders Anxiety	5.4% 9/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	9.2% 15/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Psychiatric disorders Depression	3.6% 6/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	8.0% 13/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 9/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	3.1% 5/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 7/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	5.5% 9/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Eye disorders Vision Blurred	2.4% 4/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	5.5% 9/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.
Vascular disorders Hypertension	5.4% 9/167 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.	6.7% 11/163 • Approximately 30 months All AEs were recorded starting at the first dose through 28 days after the last dose. After the 28-day follow-up period, only SAEs that were considered related to IMP were reported. The data below reflects the subjects assigned to Vorasidenib or placebo, prior to the placebo group being eligible to cross over to receive Vorasidenib, an option after the study was unblinded. AEs are based on the participants in the Safety Analysis Set, who received at least 1 dose of the treatment or placebo.

Additional Information

Clinical Studies Department

Institut de Recherches Internationales Servier (I.R.I.S.)

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Email: scientificinformation@servier.com

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