Trial Outcomes & Findings for Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma (NCT NCT04601857)
NCT ID: NCT04601857
Last Updated: 2025-12-31
Results Overview
ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1) criteria based on investigator assessment. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to less than (\<)10 millimeters (mm).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 38 months
Results posted on
2025-12-31
Participant Flow
Participants took part in the study at 18 sites in the United States, France and Spain from 07 January 2021 to 16 September 2025.
A total of 43 participants were enrolled to receive futibatinib along with pembrolizumab.
Participant milestones
| Measure |
Cohort A
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
26
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
12
|
25
|
Reasons for withdrawal
| Measure |
Cohort A
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Overall Study
Adverse Event/Serious Adverse Event
|
3
|
7
|
|
Overall Study
Disease Progression
|
2
|
4
|
|
Overall Study
Clinical Disease Progression
|
2
|
1
|
|
Overall Study
Radiological Progression
|
4
|
11
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
1
|
|
Overall Study
At the Participant's Request
|
0
|
1
|
Baseline Characteristics
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 9.86 • n=1000 Participants
|
72.2 years
STANDARD_DEVIATION 10.03 • n=1986 Participants
|
72.6 years
STANDARD_DEVIATION 9.86 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=1000 Participants
|
3 Participants
n=1986 Participants
|
6 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=1000 Participants
|
23 Participants
n=1986 Participants
|
37 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
4 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=1000 Participants
|
17 Participants
n=1986 Participants
|
24 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=1000 Participants
|
8 Participants
n=1986 Participants
|
15 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
7 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
22 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
9 Participants
n=1000 Participants
|
9 Participants
n=1986 Participants
|
18 Participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug.
ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) according to response evaluation criteria in solid tumors, version 1.1 (RECIST 1.1) criteria based on investigator assessment. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to less than (\<)10 millimeters (mm).
Outcome measures
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
47.1 percentage of participants
Interval 23.0 to 72.2
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug.
DCR was defined as the proportion of participants experiencing a best overall response of SD, PR, or CR. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis \<10 mm.
Outcome measures
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
DOR was calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to \<10 mm.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=7 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Duration of Response (DOR)
|
12.32 months
Interval 6.5 to 24.0
|
14.46 months
Interval 3.0 to 23.5
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug.
PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurred first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last tumor assessment. The 95% confidence interval (CI) for median PFS was provided using the Kaplan-Meier procedure.
Outcome measures
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
8.3 months
Interval 3.5 to 18.5
|
4.1 months
Interval 2.1 to 8.3
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug.
OS was defined as the time from the date of the first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive.
Outcome measures
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Overall Survival (OS)
|
16.2 months
Interval 6.6 to
The upper limit of the 95% CI could not be estimated, as participants were still alive at the data cut-off.
|
18.3 months
Interval 6.2 to
The upper limit of the 95% CI could not be estimated, as participants were still alive at the data cut-off.
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All treated population included all participants in all enrolled population who received at least one dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. TEAEs are defined as AEs reported up to 30 days after the last dose of any study therapy (safety follow-up) or until the start of new antitumor therapy, whichever is earlier, unless otherwise specified.
Outcome measures
| Measure |
Cohort A
n=17 Participants
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 Participants
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
17 Participants
|
26 Participants
|
Adverse Events
Cohort A
Serious events: 10 serious events
Other events: 17 other events
Deaths: 7 deaths
Cohort B
Serious events: 12 serious events
Other events: 26 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Cohort A
n=17 participants at risk
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 participants at risk
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Erysipelas
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urethral fistula
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort A
n=17 participants at risk
Participants with metastatic urothelial carcinoma (UC) and FGFR3 mutation or FGFR1-4 fusion/rearrangement received futibatinib 20 milligrams (mg), orally, once daily (QD), in a 21-day cycle for maximum duration of 590 days along with pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W), in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
Cohort B
n=26 participants at risk
Participants with metastatic UC (including participants with other FGFR or non-FGFR genetic aberrations and participants with wild type \[non-mutated\] tumors) received futibatinib 20 mg, orally, QD, in a 21-day cycle for maximum duration of 563 days along with pembrolizumab 200 mg, IV, Q3W in a 21-day cycle for a maximum of 35 doses or a maximum duration of 2 years.
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Vitreous adhesions
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
58.8%
10/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
34.6%
9/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
52.9%
9/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
53.8%
14/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
52.9%
9/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
30.8%
8/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
34.6%
9/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Endocrine disorders
Immune-mediated hyperthyroidism
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Central serous chorioretinopathy
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Keratopathy
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Eye disorders
Macular detachment
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
41.2%
7/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
34.6%
9/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Cardiac disorders
Conduction disorder
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oedema mouth
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Regurgitation
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tongue oedema
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
47.1%
8/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
34.6%
9/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
29.4%
5/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
23.5%
4/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
26.9%
7/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
30.8%
8/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Xerosis
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Chills
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Malaise
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Oral fungal infection
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Otitis externa fungal
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
41.2%
7/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
29.4%
5/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
34.6%
9/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
23.5%
4/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
19.2%
5/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood albumin increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Capillary nail refill test abnormal
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Investigations
Transaminases increased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
70.6%
12/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
50.0%
13/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
52.9%
9/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
50.0%
13/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
19.2%
5/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Cell death
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.5%
4/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
23.1%
6/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
23.1%
6/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
29.4%
5/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
30.8%
8/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Aphasia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Mental impairment
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular oedema
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
29.4%
5/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
23.1%
6/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
17.6%
3/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
11.5%
3/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
19.2%
5/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
26.9%
7/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
11.8%
2/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Anhidrosis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Mucocutaneous rash
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
15.4%
4/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Yellow nail syndrome
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
7.7%
2/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
3.8%
1/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
5.9%
1/17 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
0.00%
0/26 • Up to 38 months
All treated population included all participants in all enrolled population who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER