Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) (NCT NCT03011372)
NCT ID: NCT03011372
Last Updated: 2025-11-18
Results Overview
CR was defined as the presence of all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (Grade 1 or less fibrosis); (3) peripheral blood: white blood cells (WBC) ≤10 x 10\^9 cells/Liter (L); hemoglobin (Hgb) ≥11 grams per deciliter (g/dL); platelets ≥100 x 10\^9/L and ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts = 0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present before therapy (e.g., lymphadenopathy), including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted given subjectivity of assignment of dysplasia. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
up to 2513 days (120 21-day treatment cycles)
Results posted on
2025-11-18
Participant Flow
This study was conducted at 21 study centers in Belgium, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, and the United States.
Participant milestones
| Measure |
Pemigatinib 13.5 mg
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Pemigatinib 13.5 mg
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Sponsor Decision
|
17
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Moved to Commercial Supply of Investigational Drug
|
2
|
|
Overall Study
Received First Dose of Chemotherapy for Stem Cell Transplant
|
1
|
|
Overall Study
Sponsor's Decision
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Baseline characteristics by cohort
| Measure |
Pemigatinib 13.5 mg
n=47 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 13.25 • n=202 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Not Provided
|
2 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian and American-Indian Alaska Native
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
33 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
8 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
4 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population: all enrolled participants with an FGFR1 rearrangement and who received at least 1 dose of study drug. For this report, the full EEP included both previously treated and treatment-naive participants. Confidence intervals were calculated based on the exact method for binomial distribution.
CR was defined as the presence of all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (Grade 1 or less fibrosis); (3) peripheral blood: white blood cells (WBC) ≤10 x 10\^9 cells/Liter (L); hemoglobin (Hgb) ≥11 grams per deciliter (g/dL); platelets ≥100 x 10\^9/L and ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts = 0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present before therapy (e.g., lymphadenopathy), including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted given subjectivity of assignment of dysplasia. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
|
68.9 percentage of participants
Interval 53.35 to 81.83
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. CMR=complete metabolic response; PMR=partial metabolic response. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).
CR=all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent/equal to "mild reticulin fibrosis"; (3) WBC ≤10 x 10\^9 cells/L; Hgb ≥11 g/dL; platelets ≥100 x 10\^9/L, ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts=0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present pre-therapy, including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted. PR=all of the following improvements: (1) reduction of bone marrow blasts/blast equivalents by 50%, but remaining \>5% of cellularity (except in cases with ≤5% bone marrow blasts at baseline); (2) normalization of peripheral blood indices per CR Criterion 3; (3) extra medullary disease response of CMR/CR or PMR/PR.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
|
77.8 percentage of participants
Interval 62.91 to 88.8
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
CCyR was defined as 0% 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or fluorescence in situ hybridization (FISH). Loss of cytogenetic burden of disease (via FISH or classic karyotyping) was required to reach CCyR.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation
|
73.3 percentage of participants
Interval 58.06 to 85.4
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
PCyR was defined as the decrease from baseline of 50% or more 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or FISH.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation
|
8.9 percentage of participants
Interval 2.48 to 21.22
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment
|
15.6 percentage of participants
Interval 6.49 to 29.46
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method.
Duration of complete response was defined as the time from the first assessment of complete response to the earlier of the date of first worsening assessment after complete response or death due to any cause
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=31 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Duration of Complete Response
Investigator assessment
|
53.29 months
Interval 12.22 to
The upper limit of the confidence interval was not estimable because too few participants had worsening assessment after response or death.
|
|
Duration of Complete Response
CRC assessment
|
NA months
Interval 27.86 to
The median and the upper limit of the confidence interval were not estimable because too few participants had worsening assessment after response or death.
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Only participants with complete response or partial response were analyzed. Confidence intervals were calculated based on the exact method for binomial distribution.
Duration of response was defined as the time from the first assessment of complete response or partial response to the earlier of the date of first worsening assessment after response or death due to any cause.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Duration of Response
Investigator assessment
|
53.29 months
Interval 15.51 to
The upper limit of the confidence interval was not estimable because too few participants had events of loss of response (disease progression) or death.
|
|
Duration of Response
CRC assessment
|
NA months
Interval 27.86 to
The median and the upper limit of the confidence interval were not estimable because too few participants had events of loss of response (disease progression) or death.
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. The confidence interval was calculated using the Brookmeyer and Crowley's method. Participants who were still alive without experiencing disease progression at the time of analysis were censored at the date of the last response assessment before the cutoff date. Participants who started a new cancer therapy before disease progression were censored at the date of last response assessment before new cancer therapy start.
PFS was defined as the time from the first date of taking study drug until the date of disease progression or until death due to any cause, whichever was earlier. Disease progression was defined as the combination of 2 major criteria, 1 major and 2 minor criteria, or 3 minor criteria from the following lists. Major criteria: (1) increase in blast count; (2) evidence of cytogenetic evolution (re-appearance of a previously present or appearance of a new cytogenetic abnormality, or increase in cytogenetic burden of disease); (3) new or worsening extramedullary disease (worsening splenomegaly or extramedullary disease outside of the spleen). Minor criteria: (1) transfusion dependence; (2) significant loss of maximal response on cytopenias ≥50% decrement from maximum remission/response in granulocytes or platelets; (3) reduction in Hgb by ≥1.5g/dL from best response or from baseline as noted on complete blood count; (4) evidence of clonal evolution (molecular).
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Progression-free Survival (PFS)
Investigator assessment
|
73.89 months
Interval 54.74 to
The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death.
|
|
Progression-free Survival (PFS)
CRC assessment
|
73.89 months
Interval 29.17 to
The upper limit of the confidence interval was not estimable because too few participants had events disease progression or death.
|
SECONDARY outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated using the Brookmeyer and Crowley's method. Participants without death observed at the time of the analysis were censored at the last date known to be alive.
Overall survival was defined as as the time from the first day of taking study drug until death due to any cause
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Overall Survival
|
NA months
Interval 54.74 to
The median and the upper limit of the confidence interval were not estimable because too few participants died.
|
SECONDARY outcome
Timeframe: up to 2543 daysPopulation: Safety Population: all enrolled participants who received at least 1 dose of study drug
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=47 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
47 Participants
|
SECONDARY outcome
Timeframe: up to 2543 daysPopulation: Safety Population
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=47 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
In addition, responses were assessed by CRC based on Myeloid/Lymphoid Neoplasm International Working Group (MLN IWG) response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment
|
68.9 percentage of participants
Interval 53.35 to 81.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment
|
75.6 percentage of participants
Interval 60.46 to 87.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2513 days (120 21-day treatment cycles)Population: Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution.
In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.
Outcome measures
| Measure |
Pemigatinib 13.5 mg
n=45 Participants
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment
|
73.3 percentage of participants
Interval 58.06 to 85.4
|
Adverse Events
Pemigatinib 13.5 mg
Serious events: 27 serious events
Other events: 46 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Pemigatinib 13.5 mg
n=47 participants at risk
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
8.5%
4/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
4.3%
2/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
4.3%
2/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder obstruction
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder tamponade
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Corneal abscess
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
2.1%
1/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.1%
1/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
4.3%
2/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Oedema genital
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.3%
2/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia pseudomonal
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Postrenal failure
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonas infection
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal flattening
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Stenotrophomonas infection
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
4.3%
2/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
2.1%
1/47 • Number of events 1 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/47 • Number of events 2 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Pemigatinib 13.5 mg
n=47 participants at risk
Pemigatinib 13.5 milligrams (mg) was self-administered once daily (QD) as oral tablets on an intermittent dosing (ID) schedule or continuous dosing (CD) schedule. Participants started pemigatinib 13.5 mg on the ID schedule (i.e., 2 weeks on/1 week off) as per the initial Protocol and on the CD schedule in 21-day cycles following a Protocol amendment.
|
|---|---|
|
Infections and infestations
Cystitis
|
8.5%
4/47 • Number of events 12 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.0%
16/47 • Number of events 19 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
25.5%
12/47 • Number of events 15 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
21.3%
10/47 • Number of events 10 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
10.6%
5/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
42.6%
20/47 • Number of events 29 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.8%
6/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Corneal erosion
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
9/47 • Number of events 11 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
3/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
34.0%
16/47 • Number of events 25 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.9%
7/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ageusia
|
12.8%
6/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
12.8%
6/47 • Number of events 11 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.3%
26/47 • Number of events 29 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
34.0%
16/47 • Number of events 27 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
10.6%
5/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.3%
10/47 • Number of events 20 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
12.8%
6/47 • Number of events 10 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
21.3%
10/47 • Number of events 12 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.9%
7/47 • Number of events 14 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Blepharitis
|
8.5%
4/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
23.4%
11/47 • Number of events 14 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
17.0%
8/47 • Number of events 11 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
10.6%
5/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
8.5%
4/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
61.7%
29/47 • Number of events 51 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
19.1%
9/47 • Number of events 16 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
42.6%
20/47 • Number of events 22 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
40.4%
19/47 • Number of events 20 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.5%
12/47 • Number of events 13 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
14.9%
7/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.3%
10/47 • Number of events 11 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.3%
10/47 • Number of events 15 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
8.5%
4/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Entropion
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Epiretinal membrane
|
6.4%
3/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.0%
16/47 • Number of events 23 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.8%
6/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye discharge
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
8.5%
4/47 • Number of events 10 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
23.4%
11/47 • Number of events 15 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal infection
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.6%
5/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
14.9%
7/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.5%
4/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
6.4%
3/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
74.5%
35/47 • Number of events 59 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
10.6%
5/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
8.5%
4/47 • Number of events 13 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
3/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.5%
4/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypogeusia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
7/47 • Number of events 14 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.4%
3/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.6%
5/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
8.5%
4/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.6%
5/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Keratitis
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
17.0%
8/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Macular oedema
|
6.4%
3/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
12.8%
6/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.9%
7/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.5%
4/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.6%
5/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.8%
6/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail bed tenderness
|
6.4%
3/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.5%
4/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
8.5%
4/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
17.0%
8/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.6%
5/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
36.2%
17/47 • Number of events 19 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.5%
4/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
23.4%
11/47 • Number of events 15 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
8.5%
4/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
17.0%
8/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
17.0%
8/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
6.4%
3/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
19.1%
9/47 • Number of events 12 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.7%
13/47 • Number of events 16 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.9%
7/47 • Number of events 16 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
12.8%
6/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Photophobia
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.4%
3/47 • Number of events 4 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.8%
6/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Punctate keratitis
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
21.3%
10/47 • Number of events 19 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.5%
12/47 • Number of events 19 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
8.5%
4/47 • Number of events 7 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
10.6%
5/47 • Number of events 5 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.6%
5/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
44.7%
21/47 • Number of events 51 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Subretinal fluid
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.8%
6/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Trichiasis
|
14.9%
7/47 • Number of events 8 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.4%
3/47 • Number of events 3 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
14.9%
7/47 • Number of events 11 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.6%
5/47 • Number of events 6 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.9%
7/47 • Number of events 19 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
17.0%
8/47 • Number of events 9 • up to 2730 days
Adverse events have been reported for the Safety Population, comprised of all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
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