A Study of FT-2102 in Patients With Advanced Solid Tumors... | NCT03684811

Label	Type	Intervention Names
Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)	Experimental	Drug: FT-2102
Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)	Experimental	Drug: FT-2102
Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)	Experimental	Drug: FT-2102 Drug: Azacitidine
Phase 1b and 2 Cohort Combination (Cohort 2b)	Experimental	Drug: FT-2102 Biological: Nivolumab
Phase 1b and 2 Cohort Combination (Cohort 4b)	Experimental	Drug: FT-2102 Drug: Gemcitabine and Cisplatin

Name	Type	Description	Arm Group Labels	Other Names
FT-2102	Drug	FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.	Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)

Measure	Description	Time Frame
Number of Participants With a Dose Limiting Toxicity (DLT)	DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting <72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for >7 days.	Day 1-28
Overall Response Rate (ORR)	ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.	While on treatment

Measure	Description	Time Frame
Area Under the Plasma Concentration Versus Time Curve (AUC)	Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2	Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
Peak Plasma Concentration (Cmax)

Name	Affiliation	Role
Emma Barrett	Forma Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson		Gilbert	Arizona	85234	United States
University of Colorado Anschutz Medical Campus

PubMed Identifier	Type	Citation	Retractions
41611702	Derived	Jones RL, Groisberg R, Blay JY, Colman H, De La Fuente M, Roxburgh P, Chao MM, Tian H, Duffaud F, Bahleda R, Van Tine BA. Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial. Nat Commun. 2026 Jan 29;17(1):2224. doi: 10.1038/s41467-026-68716-6.

ID	Title	Description
FG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
FG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 28, 2020	Sep 27, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With a Dose Limiting Toxicity (DLT)

DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting <72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for >7 days.

All patients in the Safety Lead-in Period who either experienced a DLT during Cycle 1 or completed at least 75% of the prescribed Cycle 1 dose. The Safety-Lead-in Period will employ a traditional 3+3 design, whereby 3 patients with any of the solid tumors (Cohorts 2a-5) and 3 patients with gliomas (Cohort 1a) are treated with FT-2102 150 mg BID and monitored for DLTs during the first cycle of study treatment.

Posted

Count of Participants

Participants

Day 1-28

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 3A	Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG003	Cohort 5A	Other Non-Central Nervous System Solid Tumors With IDH1 Mutations Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Units	Counts
Participants	OG0003 OG0015 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0012 OG0020 OG003

Primary

Overall Response Rate (ORR)

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

The Response-Evaluable Analysis Set is defined as all patients with measurable disease at baseline are included in the Safety Analysis Set and had at least 1 post-baseline response assessment or discontinued the treatment phase due to disease progression (including death caused by disease progression) within 8 weeks (+2-week window) of the first dose of study treatment.

Posted

Count of Participants

Participants

While on treatment

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.

Secondary

Area Under the Plasma Concentration Versus Time Curve (AUC)

Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2

The PK analysis set is defined as patients from Stage 1 who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC).

Posted

Mean

Standard Deviation

h*ng/mL

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Peak Plasma Concentration (Cmax)

Peak Plasma Concentration (Cmax) was summarized for Cycle 1 and Cycle 2.

The PK analysis set is defined as patients from Stage 1 who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC).

Posted

Mean

Standard Deviation

ng / mL

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Time of Peak Plasma Concentration (Tmax)

Time of peak plasma concentration (Tmax) was summarized for Cycle 1 and Cycle 2.

The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC).

Posted

Median

Full Range

hours

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)

Time for half of the drug to be absent in blood stream following dose (T 1/2)

The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.

Posted

Mean

Standard Deviation

ng / mL

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Apparent Clearance (CL/F)

Rate at which drug is removed from the blood stream (CL/F).

Posted

Geometric Mean

Standard Deviation

units

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Rate of Drug Distribution Within the Blood Stream (Vd/F)

Rate of drug distribution within the blood stream (Vd/F)

Posted

Number

units

Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)

Olutasidenib concentration within CSF (Glioma Cohorts 1-A and 1-B only). Due to sparse data, analysis was not conducted by timepoint.

Glioma patients who had a CSF sample obtained while on study treatment were analyzed. CSF samples were not collected for cohorts 2-5, per protocol.

Posted

Mean

Standard Deviation

ng/mL

CSF sample for drug concentration was collected at Day 1 of Cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average.

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.

Units	Counts
Participants

Secondary

Progression-Free Survival (PFS)

Progression-Free Survival from time of entry on study. Progression-free survival (PFS) is defined as the time from the first dose to disease progression as determined by applicable disease criteria or death due to any cause, whichever was sooner. Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit

Posted

Median

Inter-Quartile Range

weeks

From time of entry on study through progression, up to 24 weeks, on average

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.

Secondary

Time to Progression (TTP)

Time to progression is defined as the time (in weeks) from start of treatment until disease specified progression.

Posted

Median

Inter-Quartile Range

weeks

From first dose of study drug through time of disease progression

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Duration of Response (DOR)

Duration of response (DOR), defined as the time from the first response to documented disease progression as determined by applicable disease criteria. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5). Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit

Response-Evaluable Analysis Set defined as all patients with measurable disease at baseline are included in the Safety Analysis Set and had at least 1 post-baseline response assessment or discontinued the treatment phase due to disease progression (including death caused by disease progression) within 8 weeks (+2-week window) of the first dose of study treatment. Duration of response was calculated on the subset of patients in the Response Evaluable Set who experienced an Overall Response.

Posted

Median

Inter-Quartile Range

weeks

From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 44 weeks

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.

Secondary

Overall Survival (OS)

Overall survival (OS), defined as the time in weeks from the first dose to death due to any cause or date last known alive at end of follow-up

Safety Analysis Set - Patients who have received at least one dose of study medication.

Posted

Median

Inter-Quartile Range

weeks

From date of first dose until the date of death from any cause, assessed up to 101 weeks

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.

Secondary

Time to Response (TTR)

Time to response (TTR) in weeks. TTR is defined as the time from first dose to first response. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5).

Posted

Median

Inter-Quartile Range

weeks

Response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.

ID	Title	Description
OG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
OG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
OG002	Cohort 2A

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disease Progression	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0006 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG0035 affected23 at risk EG0046 affected24 at risk EG0051 affected6 at risk
Pyrexia	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Abdominal infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Sepsis	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hepatic enzyme abnormal	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Platelet count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Transaminases increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Seizure	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Syncope	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Embolism	Vascular disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG0032 affected23 at risk EG0040 affected24 at risk EG0050 affected6 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Vision blurred	Eye disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Diplopia	Eye disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG00014 affected26 at risk EG0014 affected6 at risk EG0026 affected8 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0007 affected26 at risk EG0012 affected6 at risk EG0024 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0008 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0005 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG00013 affected26 at risk EG0012 affected6 at risk EG0023 affected8 at risk EG003
Disease progression	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0006 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Asthenia	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Chills	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
General physical health deterioration	General disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0004 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Abdominal infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Bronchitis	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Candida infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Rash pustular	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Sinusitis	Infections and infestations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (21.0)	Non-systematic Assessment	EG0007 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0008 affected26 at risk EG0015 affected6 at risk EG0023 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0005 affected26 at risk EG0014 affected6 at risk EG0022 affected8 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0012 affected6 at risk EG0024 affected8 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0012 affected6 at risk EG0021 affected8 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0012 affected6 at risk EG0022 affected8 at risk EG003
Red blood cell count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Platelet count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0004 affected26 at risk EG0012 affected6 at risk EG0020 affected8 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Weight decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0013 affected6 at risk EG0021 affected8 at risk EG003
Blood creatinine increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
White blood cell count decreased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Weight increased	Investigations	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0024 affected8 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0005 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0008 affected26 at risk EG0011 affected6 at risk EG0022 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0004 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Seizure	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0005 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Aphasia	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (21.0)	Non-systematic Assessment	EG0004 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Agitation	Psychiatric disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected6 at risk EG0021 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0003 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0001 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0010 affected6 at risk EG0020 affected8 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Hypertension	Vascular disorders	MedDRA (21.0)	Non-systematic Assessment	EG0004 affected26 at risk EG0010 affected6 at risk EG0022 affected8 at risk EG003
Hot flush	Vascular disorders	MedDRA (21.0)	Non-systematic Assessment	EG0002 affected26 at risk EG0011 affected6 at risk EG0020 affected8 at risk EG003
Hypotension	Vascular disorders	MedDRA (21.0)	Non-systematic Assessment	EG0000 affected26 at risk EG0010 affected6 at risk EG0021 affected8 at risk EG003

ID	Term
D005909	Glioblastoma
D006528	Carcinoma, Hepatocellular
D001650	Bile Duct Neoplasms
D018281	Cholangiocarcinoma

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue
D000230	Adenocarcinoma
D002277	Carcinoma
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases
D001661	Biliary Tract Neoplasms
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D003841	Deoxycytidine
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
BG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.
BG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
BG003	Cohort 3A	Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
BG004	Cohort 4A	Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
BG005	Cohort 5A	Other Non-Central Nervous System Solid Tumors With IDH1 Mutations Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1A	Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	2	26	11	26	26	26
EG001	Cohort 1B	Glioma Olutasidenib (150 QD or 150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. Azacitidine (75 mg/m2/day × 7 days every 28 days) was administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib.	0	6	3	6	6	6
EG002	Cohort 2A	Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas) Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	0	8	5	8	8	8
EG003	Cohort 3A	Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	2	23	12	23	21	23
EG004	Cohort 4A	Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	4	24	9	24	23	24
EG005	Cohort 5A	Other Non-Central Nervous System Solid Tumors With IDH1 Mutations Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	1	6	1	6	6	6

ID	Term
C000710173	olutasidenib
D001374	Azacitidine
D000077594	Nivolumab
D000093542	Gemcitabine
D002945	Cisplatin