Trial Outcomes & Findings for A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation (NCT NCT03684811)

NCT ID: NCT03684811

Last Updated: 2023-11-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 93 participants
• Primary outcome timeframe: Day 1-28
• Results posted on: 2023-11-18

Participant Flow

Participant milestones

Measure	Cohort 1A Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	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.	Cohort 2B 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. Nivolumab (240 mg intravenously every 2 weeks) was to be administered in combination with olutasidenib. No patients were enrolled into Cohort 2b.	Cohort 3A Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 3B Chondrosarcoma Olutasidenib (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 to be administered intravenously (or subcutaneously) daily for 7 days in combination with olutasidenib. No patients were enrolled in Cohort 3b.	Cohort 4A Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 4B Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met. GemCis (cisplatin \[25 mg/m2\] followed by gemcitabine \[1000 mg/m2\], each administered on Days 1 and 8, every 3 weeks, for 8 cycles of up to 24 weeks) was to be administered in combination with olutasidenib. No patients were enrolled in Cohort 4b.	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.
Overall Study STARTED	26	6	8	0	23	0	24	0	6
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	26	6	8	0	23	0	24	0	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

Baseline characteristics by cohort

Measure	Cohort 1A n=26 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 2A n=8 Participants 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.	Cohort 3A n=23 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 4A n=24 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 Participants 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.	Total n=93 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 9.13 • n=5 Participants	42.0 years STANDARD_DEVIATION 7.21 • n=7 Participants	59.9 years STANDARD_DEVIATION 10.47 • n=5 Participants	55.1 years STANDARD_DEVIATION 10.68 • n=4 Participants	57.1 years STANDARD_DEVIATION 12.56 • n=21 Participants	61.3 years STANDARD_DEVIATION 18.3 • n=8 Participants	52.7 years STANDARD_DEVIATION 12.6 • n=8 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants	4 Participants n=8 Participants	44 Participants n=8 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants	7 Participants n=21 Participants	2 Participants n=8 Participants	49 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants	16 Participants n=21 Participants	4 Participants n=8 Participants	67 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	19 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	3 Participants n=8 Participants	71 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	16 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1-28

Population: 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.

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.

Outcome measures

Measure	Cohort 1A n=3 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=5 Participants 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.	Cohort 3A n=3 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=1 Participants 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.	Cohort 4A Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.
Number of Participants With a Dose Limiting Toxicity (DLT)	0 Participants	2 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: While on treatment

Population: 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.

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.

Outcome measures

Measure	Cohort 1A n=25 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=5 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=21 Participants 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.	Cohort 4A n=19 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 Participants 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.
Overall Response Rate (ORR)	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

Population: 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).

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=9 Participants 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.	Cohort 4A n=12 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=5 Participants 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.
Area Under the Plasma Concentration Versus Time Curve (AUC) Cycle 1	6840 h*ng/mL Standard Deviation 3062.9	6190 h*ng/mL Standard Deviation 2113.0	13140 h*ng/mL Standard Deviation 6018.9	12000 h*ng/mL Standard Deviation 2907.1	10780 h*ng/mL Standard Deviation 6379.1	11030 h*ng/mL Standard Deviation 6781.6
Area Under the Plasma Concentration Versus Time Curve (AUC) Cycle 2	20390 h*ng/mL Standard Deviation 5975.5	21210 h*ng/mL Standard Deviation 5775.0	27580 h*ng/mL Standard Deviation 4531.3	28170 h*ng/mL Standard Deviation 9052.5	24400 h*ng/mL Standard Deviation 8663.1	39540 h*ng/mL Standard Deviation 12573

SECONDARY outcome

Timeframe: 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).

Population: 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).

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=9 Participants 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.	Cohort 4A n=12 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=5 Participants 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.
Peak Plasma Concentration (Cmax) Cycle 1	388.1 ng / mL Standard Deviation 154.92	369.5 ng / mL Standard Deviation 127.84	879.4 ng / mL Standard Deviation 432.37	863.4 ng / mL Standard Deviation 313.71	744.1 ng / mL Standard Deviation 526.73	815.4 ng / mL Standard Deviation 432.32
Peak Plasma Concentration (Cmax) Cycle 2	2965 ng / mL Standard Deviation 917.89	2870 ng / mL Standard Deviation 540.28	4045 ng / mL Standard Deviation 527.02	4104 ng / mL Standard Deviation 1326.0	3650 ng / mL Standard Deviation 985.06	5663 ng / mL Standard Deviation 1897.8

SECONDARY outcome

Timeframe: 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).

Population: 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).

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=9 Participants 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.	Cohort 4A n=12 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=5 Participants 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.
Time of Peak Plasma Concentration (Tmax) Cycle 2	1.97 hours Interval 0.0 to 7.57	4.00 hours Interval 3.97 to 4.05	1.05 hours Interval 1.0 to 7.85	1.98 hours Interval 0.95 to 4.0	1.04 hours Interval 0.0 to 4.22	1.52 hours Interval 0.0 to 7.58
Time of Peak Plasma Concentration (Tmax) Cycle 1	4.18 hours Interval 1.95 to 20.25	3.95 hours Interval 1.92 to 27.23	15.27 hours Interval 2.03 to 24.33	16.37 hours Interval 1.02 to 23.92	7.50 hours Interval 1.0 to 24.0	4.17 hours Interval 1.0 to 23.05

SECONDARY outcome

Timeframe: 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).

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=8 Participants 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.	Cohort 4A n=11 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=4 Participants 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.
Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA ng / mL Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.

SECONDARY outcome

Timeframe: 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).

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=8 Participants 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.	Cohort 4A n=11 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=4 Participants 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.
Apparent Clearance (CL/F)	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Standard Deviation NA Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.

SECONDARY outcome

Timeframe: 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).

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=9 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=8 Participants 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.	Cohort 4A n=11 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=4 Participants 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.
Rate of Drug Distribution Within the Blood Stream (Vd/F)	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.	NA units Results were not estimable for this outcome measure because of the limited sampling interval post Day 1.

SECONDARY outcome

Timeframe: 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.

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=2 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 3A Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 4A Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.
Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)	27.15 ng/mL Standard Deviation 6.57	—	—	—	—	—

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=25 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=5 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=21 Participants 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.	Cohort 4A n=19 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 Participants 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.
Progression-Free Survival (PFS)	8.21 weeks Interval 7.14 to 37.5	8.29 weeks Interval 8.14 to 9.43	NA weeks Interval 7.0 to Median not reached	8.57 weeks Interval 7.43 to 22.14	8.29 weeks Interval 7.0 to 17.71	8.07 weeks Interval 7.57 to 31.0

SECONDARY outcome

Timeframe: From first dose of study drug through time of disease progression

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=25 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=5 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=21 Participants 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.	Cohort 4A n=19 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 Participants 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.
Time to Progression (TTP)	8.21 weeks Interval 7.14 to 37.5	8.29 weeks Interval 8.14 to 9.43	NA weeks Interval 7.0 to Median not reached	15.00 weeks Interval 7.43 to 24.0	13.86 weeks Interval 7.29 to 24.14	8.14 weeks Interval 8.0 to 31.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Measure	Cohort 1A n=2 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 3A n=1 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 4A Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.
Duration of Response (DOR)	43.71 weeks Interval 43.71 to 43.71	—	NA weeks Median Not Reached	—	—	—

SECONDARY outcome

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

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

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

Outcome measures

Measure	Cohort 1A n=26 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 Participants 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.	Cohort 3A n=8 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=23 Participants 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.	Cohort 4A n=24 Participants Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 Participants 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.
Overall Survival (OS)	75.00 weeks Interval 45.86 to Upper Quartile not estimable due to number of censored patients	NA weeks Median Not Reached due to number of censored patients	NA weeks Interval 32.0 to Median Not Reached due to number of censored patients	NA weeks Interval 23.14 to Median Not Reached due to number of censored patients	36.43 weeks Interval 10.29 to Upper Quartile not estimable due to number of censored patients	NA weeks Interval 33.71 to Median Not Reached due to number of censored patients

SECONDARY outcome

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

Population: 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.

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).

Outcome measures

Measure	Cohort 1A n=2 Participants Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 3A n=1 Participants Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.	Cohort 4A Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	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.
Time to Response (TTR)	38.07 weeks Interval 8.29 to 67.86	—	31.43 weeks Interval 31.43 to 31.43	—	—	—

Adverse Events

Cohort 1A

Serious events: 11 serious events

Other events: 26 other events

Deaths: 2 deaths

Cohort 1B

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2A

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 3A

Serious events: 12 serious events

Other events: 21 other events

Deaths: 2 deaths

Cohort 4A

Serious events: 9 serious events

Other events: 23 other events

Deaths: 4 deaths

Cohort 5A

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cohort 1A n=26 participants at risk Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 participants at risk 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.	Cohort 2A n=8 participants at risk 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.	Cohort 3A n=23 participants at risk Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 4A n=24 participants at risk Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 participants at risk 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.
General disorders Disease Progression	23.1% 6/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	21.7% 5/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 6/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Pyrexia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Anal incontinence	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Ascites	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Nausea	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Vomiting	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Hepatobiliary disorders Hepatitis acute	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Abdominal infection	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Sepsis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Urinary tract infection	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Hepatic enzyme abnormal	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Hepatic enzyme increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Neutrophil count decreased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Platelet count decreased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Transaminases increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Seizure	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Haemorrhage intracranial	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Headache	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Syncope	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Vascular disorders Embolism	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Vascular disorders Pelvic venous thrombosis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)

Other adverse events

Measure	Cohort 1A n=26 participants at risk Glioma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 1B n=6 participants at risk 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.	Cohort 2A n=8 participants at risk 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.	Cohort 3A n=23 participants at risk Chondrosarcoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 4A n=24 participants at risk Intrahepatic Cholangiocarcinoma Olutasidenib (150 mg BID) was administered orally in continuous 28 day cycles until criteria for treatment discontinuation were met.	Cohort 5A n=6 participants at risk 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.
Nervous system disorders Seizure	19.2% 5/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Cardiac disorders Tachycardia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Cardiac disorders Sinus bradycardia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Cardiac disorders Sinus tachycardia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Eye disorders Vision blurred	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Eye disorders Diplopia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Nausea	53.8% 14/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	75.0% 6/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	65.2% 15/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	37.5% 9/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Constipation	26.9% 7/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 4/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	30.4% 7/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 6/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 3/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Diarrhoea	30.8% 8/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	20.8% 5/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 3/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Vomiting	19.2% 5/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	13.0% 3/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 3/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Abdominal pain	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Dyspepsia	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Stomatitis	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 4/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Dysphagia	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Toothache	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Dry mouth	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Mouth ulceration	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Hiatus hernia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Fatigue	50.0% 13/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	37.5% 3/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	30.4% 7/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 8/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Disease progression	23.1% 6/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	21.7% 5/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 6/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Asthenia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	17.4% 4/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	20.8% 5/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Non-cardiac chest pain	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Oedema peripheral	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Pyrexia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders Chills	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
General disorders General physical health deterioration	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Hepatobiliary disorders Hepatic pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Hepatobiliary disorders Cholestasis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Upper respiratory tract infection	15.4% 4/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Abdominal infection	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Bronchitis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Candida infection	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Urinary tract infection	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Fungal skin infection	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Rash pustular	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Infections and infestations Sinusitis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Injury, poisoning and procedural complications Fall	26.9% 7/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Alanine aminotransferase increased	30.8% 8/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	83.3% 5/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	37.5% 3/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	30.4% 7/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	37.5% 9/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Aspartate aminotransferase increased	19.2% 5/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	30.4% 7/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	45.8% 11/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Blood alkaline phosphatase increased	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 4/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	26.1% 6/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 8/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	66.7% 4/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Gamma-glutamyltransferase increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	26.1% 6/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Blood bilirubin increased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	17.4% 4/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Red blood cell count decreased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 4/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Platelet count decreased	15.4% 4/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 4/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Lymphocyte count decreased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	13.0% 3/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Weight decreased	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	17.4% 4/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Neutrophil count decreased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 3/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Blood creatinine increased	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Hepatic enzyme increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations White blood cell count decreased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Bilirubin conjugated increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Electrocardiogram QT prolonged	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Investigations Weight increased	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Decreased appetite	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 4/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	43.5% 10/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	20.8% 5/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	50.0% 3/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	20.8% 5/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypokalaemia	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypophosphataemia	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hyperglycaemia	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	33.3% 2/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Metabolism and nutrition disorders Acidosis	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	13.0% 3/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	17.4% 4/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Flank pain	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Muscle spasms	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Back pain	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Muscular weakness	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Dysgeusia	19.2% 5/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	21.7% 5/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Headache	30.8% 8/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Dizziness	15.4% 4/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	13.0% 3/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Paraesthesia	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Aphasia	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Hemiparesis	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Cognitive disorder	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Hypoaesthesia	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Neuropathy peripheral	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Balance disorder	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Nervous system disorders Hyperaesthesia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Psychiatric disorders Insomnia	15.4% 4/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	17.4% 4/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.3% 2/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Psychiatric disorders Confusional state	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Psychiatric disorders Agitation	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Psychiatric disorders Sleep disorder	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Renal and urinary disorders Renal failure	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Renal and urinary disorders Urinary incontinence	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	21.7% 5/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 4/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	21.7% 5/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Epistaxis	11.5% 3/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Pruritus	3.8% 1/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	8.7% 2/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 4/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 3/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Dermatitis acneiform	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Vascular disorders Hypertension	15.4% 4/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	25.0% 2/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	13.0% 3/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.2% 1/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Vascular disorders Hot flush	7.7% 2/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	16.7% 1/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	4.3% 1/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)
Vascular disorders Hypotension	0.00% 0/26 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	12.5% 1/8 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/23 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/24 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)	0.00% 0/6 • From first dose of study drug up to 28 days after last dose (Up to approximately 2 years)

Additional Information

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