Trial Outcomes & Findings for Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) (NCT NCT03822117)

NCT ID: NCT03822117

Last Updated: 2025-11-04

Results Overview

Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 111 participants
• Primary outcome timeframe: up to 449 days
• Results posted on: 2025-11-04

Participant Flow

This study enrolled participants at 49 study sites in the United States, South Korea, United Kingdom, France, Italy, Israel, Germany, Spain, Denmark, and Japan.

Participant milestones

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Overall Study STARTED	49	32	26	4
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	49	32	26	4

Reasons for withdrawal

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Overall Study Death	18	17	12	4
Overall Study Lost to Follow-up	1	2	3	0
Overall Study Study Terminated by Sponsor	25	11	6	0
Overall Study Withdrawal by Subject	4	0	3	0
Overall Study Disease Progression	1	2	1	0
Overall Study Never Returned to Hospital	0	0	1	0

Baseline Characteristics

Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Baseline characteristics by cohort

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements n=26 Participants Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other n=4 Participants Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Total n=111 Participants Total of all reporting groups
Race/Ethnicity, Customized White	38 Participants n=15 Participants	20 Participants n=161 Participants	16 Participants n=100 Participants	0 Participants n=3 Participants	74 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=15 Participants	0 Participants n=161 Participants	1 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	9 Participants n=15 Participants	9 Participants n=161 Participants	7 Participants n=100 Participants	4 Participants n=3 Participants	29 Participants n=8 Participants
Race/Ethnicity, Customized Participant Declined to Provide	1 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Not Available	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Not Required in Country of Origin	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=15 Participants	1 Participants n=161 Participants	1 Participants n=100 Participants	0 Participants n=3 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	44 Participants n=15 Participants	25 Participants n=161 Participants	20 Participants n=100 Participants	3 Participants n=3 Participants	92 Participants n=8 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 11.51 • n=15 Participants	66.0 years STANDARD_DEVIATION 10.04 • n=161 Participants	61.5 years STANDARD_DEVIATION 13.32 • n=100 Participants	48.0 years STANDARD_DEVIATION 14.45 • n=3 Participants	61.4 years STANDARD_DEVIATION 12.11 • n=8 Participants
Sex: Female, Male Female	28 Participants n=15 Participants	19 Participants n=161 Participants	14 Participants n=100 Participants	1 Participants n=3 Participants	62 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=15 Participants	13 Participants n=161 Participants	12 Participants n=100 Participants	3 Participants n=3 Participants	49 Participants n=8 Participants
Race/Ethnicity, Customized Missing	1 Participants n=15 Participants	1 Participants n=161 Participants	2 Participants n=100 Participants	0 Participants n=3 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=15 Participants	2 Participants n=161 Participants	3 Participants n=100 Participants	1 Participants n=3 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=15 Participants	2 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Captured as "Other"	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: up to 483 days

Population: Efficacy Evaluable Population: all enrolled participants in Cohorts A, B, and C who received at least 1 dose of pemigatinib. Confidence interval was calculated based on the exact method for binomial distribution.

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements	26.5 percentage of participants Interval 14.95 to 41.08	—	—	—

PRIMARY outcome

Timeframe: up to 449 days

Population: Efficacy Evaluable Population. Confidence interval was calculated based on the exact method for binomial distribution.

Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations	—	9.4 percentage of participants Interval 1.98 to 25.02	—	—

SECONDARY outcome

Timeframe: up to 532 days

Population: Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method.

PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	4.53 months Interval 3.58 to 6.28	3.68 months Interval 2.07 to 4.47	—	—

SECONDARY outcome

Timeframe: up to 24.90 months

Population: Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.

Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=13 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=3 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	7.79 months Interval 4.17 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.	6.93 months Interval 4.01 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.	—	—

SECONDARY outcome

Timeframe: up to 532 days

Population: Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.

Overall survival was defined as the time from the first dose of study drug to death of any cause.

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	17.48 months Interval 7.79 to The upper limit of the confidence interval was not estimable because too few participants had died.	11.37 months Interval 6.57 to The upper limit of the confidence interval was not estimable because too few participants had died.	—	—

SECONDARY outcome

Timeframe: up to 651 days

Population: Safety Population: all enrolled participants who received at least 1 dose of pemigatinib

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.

Outcome measures

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 Participants Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 Participants Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements n=26 Participants Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other n=4 Participants Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE) Treatment-related AEs	46 Participants	32 Participants	26 Participants	4 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE) TEAEs	49 Participants	32 Participants	26 Participants	4 Participants

Adverse Events

Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements

Serious events: 21 serious events

Other events: 49 other events

Deaths: 18 deaths

Cohort B: Known or Likely Activating FGFR1-3 Mutations

Serious events: 7 serious events

Other events: 32 other events

Deaths: 17 deaths

Cohort C: Other FGFR Mutations or Arrangements

Serious events: 10 serious events

Other events: 26 other events

Deaths: 13 deaths

Other

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Total

Serious events: 40 serious events

Other events: 111 other events

Deaths: 52 deaths

Serious adverse events

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 participants at risk Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 participants at risk Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements n=26 participants at risk Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other n=4 participants at risk Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Total n=111 participants at risk Total
Gastrointestinal disorders Abdominal pain	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Ascites	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Hepatobiliary disorders Bile duct stenosis	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Hepatobiliary disorders Biliary obstruction	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Blood bilirubin increased	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Blood creatinine increased	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Cellulitis	2.0% 1/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Hepatobiliary disorders Cholangitis	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Psychiatric disorders Confusional state	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Constipation	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Eye disorders Corneal erosion	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Cutaneous calcification	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Fascial infection	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Fatigue	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Blood and lymphatic system disorders Febrile neutropenia	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders General physical health deterioration	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Haematemesis	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Headache	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Hydronephrosis	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hyponatraemia	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Implant site infection	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Intestinal obstruction	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Cardiac disorders Long QT syndrome	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Nausea	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Obstruction gastric	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Oedema peripheral	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Pathological fracture	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Pneumonia	2.0% 1/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Pyelonephritis acute	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Sepsis	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Spinal cord compression	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Product Issues Stent malfunction	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Ureteric obstruction	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Urinary tract obstruction	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Vomiting	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.

Other adverse events

Measure	Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements n=49 participants at risk Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort B: Known or Likely Activating FGFR1-3 Mutations n=32 participants at risk Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Cohort C: Other FGFR Mutations or Arrangements n=26 participants at risk Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Other n=4 participants at risk Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	Total n=111 participants at risk Total
Eye disorders Dry eye	24.5% 12/49 • Number of events 13 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	28.1% 9/32 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.4% 4/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	22.5% 25/111 • Number of events 28 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Abdominal pain	14.3% 7/49 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	13.5% 15/111 • Number of events 18 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Abdominal pain upper	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.3% 7/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Psychiatric disorders Agitation	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Alanine aminotransferase increased	12.2% 6/49 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.6% 5/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.6% 14/111 • Number of events 16 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Alopecia	40.8% 20/49 • Number of events 20 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	53.1% 17/32 • Number of events 21 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	30.8% 8/26 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	40.5% 45/111 • Number of events 49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Blood and lymphatic system disorders Anaemia	16.3% 8/49 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.6% 14/111 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	22.4% 11/49 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	34.4% 11/32 • Number of events 14 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	20.7% 23/111 • Number of events 27 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Aspartate aminotransferase increased	10.2% 5/49 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.6% 14/111 • Number of events 20 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Asthenia	16.3% 8/49 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	34.4% 11/32 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	30.8% 8/26 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	24.3% 27/111 • Number of events 32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Back pain	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.2% 8/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Blood alkaline phosphatase increased	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Blood creatinine increased	20.4% 10/49 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	16.2% 18/111 • Number of events 18 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations COVID-19	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Cheilitis	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Chronic kidney disease	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Conjunctivitis	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.3% 7/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Constipation	36.7% 18/49 • Number of events 20 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	40.6% 13/32 • Number of events 18 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	23.1% 6/26 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	33.3% 37/111 • Number of events 44 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.8% 6/32 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.9% 11/111 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Cystitis	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Decreased appetite	20.4% 10/49 • Number of events 14 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	37.5% 12/32 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	24.3% 27/111 • Number of events 34 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Dehydration	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Psychiatric disorders Depression	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Diarrhoea	38.8% 19/49 • Number of events 28 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	53.1% 17/32 • Number of events 30 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	26.9% 7/26 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	38.7% 43/111 • Number of events 65 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Dizziness	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.3% 7/111 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Dry mouth	26.5% 13/49 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	34.4% 11/32 • Number of events 13 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	26.9% 7/26 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	28.8% 32/111 • Number of events 37 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Dry skin	12.2% 6/49 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.8% 6/32 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	16.2% 18/111 • Number of events 21 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Dysgeusia	20.4% 10/49 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	43.8% 14/32 • Number of events 17 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	23.1% 6/26 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	27.0% 30/111 • Number of events 36 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Dyspepsia	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	5.4% 6/111 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Dysphagia	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Malaise	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	4.5% 5/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	8.1% 9/111 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	8.1% 9/111 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Erythema	8.2% 4/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Injury, poisoning and procedural complications Fall	6.1% 3/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Fatigue	20.4% 10/49 • Number of events 14 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	28.1% 9/32 • Number of events 11 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.4% 4/26 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	20.7% 23/111 • Number of events 29 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Headache	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.3% 7/111 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Hepatic enzyme increased	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.90% 1/111 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hypercalcaemia	4.1% 2/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.2% 8/111 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hyperglycaemia	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hyperphosphataemia	91.8% 45/49 • Number of events 72 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	84.4% 27/32 • Number of events 51 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	65.4% 17/26 • Number of events 27 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	100.0% 4/4 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	83.8% 93/111 • Number of events 154 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Vascular disorders Hypertension	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hypokalaemia	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hypomagnesaemia	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.3% 7/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hyponatraemia	8.2% 4/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	5.4% 6/111 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Hypophosphataemia	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 1/4 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.0% 10/111 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Vascular disorders Hypotension	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	5.4% 6/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Psychiatric disorders Insomnia	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Eye disorders Keratitis	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Lipase increased	4.1% 2/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	4.5% 5/111 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Muscle spasms	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Myalgia	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.0% 10/111 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Nail discolouration	14.3% 7/49 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.7% 13/111 • Number of events 13 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Nail disorder	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.0% 10/111 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Nail infection	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Nasal dryness	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Nausea	22.4% 11/49 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 8/32 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	23.1% 6/26 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	50.0% 2/4 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	24.3% 27/111 • Number of events 33 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Neutrophil count decreased	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Oedema peripheral	12.2% 6/49 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.6% 5/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.7% 13/111 • Number of events 13 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Onychalgia	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Onycholysis	4.1% 2/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.6% 5/32 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.0% 10/111 • Number of events 12 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Onychomadesis	14.3% 7/49 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.8% 6/32 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.4% 4/26 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.3% 17/111 • Number of events 18 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 7/49 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/32 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.0% 10/111 • Number of events 11 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	26.5% 13/49 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	25.0% 8/32 • Number of events 11 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	23.4% 26/111 • Number of events 31 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Paronychia	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.8% 6/32 • Number of events 7 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	11.5% 3/26 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.6% 14/111 • Number of events 15 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Presyncope	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Pruritus	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	12.5% 4/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	5.4% 6/111 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Pyrexia	4.1% 2/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	50.0% 2/4 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.2% 8/111 • Number of events 8 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Rash	6.1% 3/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	4.5% 5/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Renal failure	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	4.5% 5/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Eye disorders Serous retinal detachment	10.2% 5/49 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	8.1% 9/111 • Number of events 10 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	1.8% 2/111 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Stomatitis	55.1% 27/49 • Number of events 39 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	53.1% 17/32 • Number of events 25 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	50.0% 13/26 • Number of events 21 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	50.0% 2/4 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	53.2% 59/111 • Number of events 87 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Nervous system disorders Taste disorder	2.0% 1/49 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	4.5% 5/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Blood and lymphatic system disorders Thrombocytopenia	4.1% 2/49 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Renal and urinary disorders Urinary retention	8.2% 4/49 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	5.4% 6/111 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Infections and infestations Urinary tract infection	12.2% 6/49 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.6% 5/32 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.4% 4/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	13.5% 15/111 • Number of events 16 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Eye disorders Vision blurred	10.2% 5/49 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	9.4% 3/32 • Number of events 4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/26 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.2% 8/111 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Metabolism and nutrition disorders Vitamin D deficiency	2.0% 1/49 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.1% 1/32 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.6% 4/111 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Gastrointestinal disorders Vomiting	20.4% 10/49 • Number of events 14 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	15.6% 5/32 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	19.2% 5/26 • Number of events 5 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.0% 20/111 • Number of events 25 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
Investigations Weight decreased	16.3% 8/49 • Number of events 9 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	18.8% 6/32 • Number of events 6 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	7.7% 2/26 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	14.4% 16/111 • Number of events 17 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
General disorders Xerosis	0.00% 0/49 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	6.2% 2/32 • Number of events 2 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	3.8% 1/26 • Number of events 1 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	0.00% 0/4 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.	2.7% 3/111 • Number of events 3 • up to 651 days Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER