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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002596-10 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemigatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemigatinib | Drug | Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy. Participants will receive either the intermittent dose (as written) or continuous dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | up to 2513 days (120 21-day treatment cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment | 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. | up to 2513 days (120 21-day treatment cycles) |
Inclusion Criteria:
Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
Eligible subjects must:
Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
Life expectancy ≥ 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philomena Collucci, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41180818 | Derived | Al-Bazaz M, Forstreuter A, Hammada I, Hille J, Wagner JN, Reinert J, Wehrhahn J, Bokemeyer C, Fiedler W. Acute Lymphoblastic Leukemia Characterized by Rare BCR::FGFR1 Translocation: A Case Report With Literature Review. Case Rep Hematol. 2025 Oct 23;2025:8892036. doi: 10.1155/crh/8892036. eCollection 2025. | |
| 40856555 | Derived |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 21 study centers in Belgium, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2023 | Oct 21, 2025 |
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|
| up to 2513 days (120 21-day treatment cycles) |
| Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | 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. | up to 2513 days (120 21-day treatment cycles) |
| Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | 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. | up to 2513 days (120 21-day treatment cycles) |
| Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | up to 2513 days (120 21-day treatment cycles) |
| Duration of Complete Response | 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 | up to 2513 days (120 21-day treatment cycles) |
| Duration of Response | 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. | up to 2513 days (120 21-day treatment cycles) |
| Progression-free Survival (PFS) | 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). | up to 2513 days (120 21-day treatment cycles) |
| Overall Survival | Overall survival was defined as as the time from the first day of taking study drug until death due to any cause | up to 2513 days (120 21-day treatment cycles) |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. | up to 2543 days |
| Number of Participants With Any ≥Grade 3 TEAE | 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. | up to 2543 days |
| Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | up to 2513 days (120 21-day treatment cycles) |
| Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | up to 2513 days (120 21-day treatment cycles) |
| Duarte |
| California |
| 91010 |
| United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| Emory University - Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical Centers | New York | New York | 10021 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz | Linz | 04010 | Austria |
| Medical University of Vienna | Vienna | 01090 | Austria |
| Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus | Vienna | 01140 | Austria |
| Universitair Ziekenhuis (Uz) Leuven | Leuven | 03000 | Belgium |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Leon Berard | Lyon | 69373 | France |
| Chu de Nice - Hospital L Archet | Nice | 06202 | France |
| Hospital Saint Louis | Paris | 75475 | France |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole | Toulouse | 31059 | France |
| University Medical Center Rwth Aachen | Aachen | D-52074 | Germany |
| Universitatsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Universitatsklinikum Jena | Jena | 07740 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Ospedale Papa Giovanni Xxiii | Bergamo | 24127 | Italy |
| Azienda Ospedaliero-Universitaria Careggi (Aouc) | Florence | 50134 | Italy |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Ntt Medical Center Tokyo | Tokyo | 141-8625 | Japan |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Inselspital - Universitaetsspital Bern | Bern | 03010 | Switzerland |
| Universitatsspital Zurich | Zurich | 08091 | Switzerland |
| Guys and St Thomas Nhs Foundation Trust | London | SE1 9RT | United Kingdom |
| Oxford University Hospitals Nhs Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| Verstovsek S, Kiladjian JJ, Vannucchi AM, Patel JL, Rambaldi A, Shomali WE, Oh ST, Usuki K, Harrison CN, Ritchie EK, Akard LP, Hernandez-Boluda JC, Huguet F, Colucci P, Zhen H, Oliveira N, Gilmartin A, Langford C, George TI, Reiter A, Gotlib J. Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement. NEJM Evid. 2025 Sep;4(9):EVIDoa2500017. doi: 10.1056/EVIDoa2500017. Epub 2025 Aug 26. |
| 37934000 | Derived | Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
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| |||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment | 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. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | 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. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | 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. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Complete Response | 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 | Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method. | Posted | Median | 95% Confidence Interval | months | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | 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. | 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. | Posted | Median | 95% Confidence Interval | months | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | 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). | 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. | Posted | Median | 95% Confidence Interval | months | up to 2513 days (120 21-day treatment cycles) |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as as the time from the first day of taking study drug until death due to any cause | 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. | Posted | Median | 95% Confidence Interval | months | up to 2513 days (120 21-day treatment cycles) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. | Safety Population: all enrolled participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | up to 2543 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Any ≥Grade 3 TEAE | 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. | Safety Population | Posted | Count of Participants | Participants | up to 2543 days |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 16 | 47 | 27 | 47 | 46 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder tamponade | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Corneal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Heart failure with preserved ejection fraction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal flattening | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail bed tenderness | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2021 | Oct 21, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D004802 | Eosinophilia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705477 | pemigatinib |
Not provided
Not provided
Not provided
| Asian |
|
| Missing |
|
| Not Provided |
|
| White/Caucasian and American-Indian Alaska Native |
|
| African |
|
| Not Reported |
|
| Unknown |
|
| Captured as "Other" in Database |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|