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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation | |
| 2017-001624-22 | EudraCT Number |
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The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW | Experimental | Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. |
|
| Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD | Experimental | Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib tablets administered orally with water and without regard to food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria | ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions. | Up to approximately 148 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria | CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Zheng, MD, PhD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates - Biltmore Cancer Center | Phoenix | Arizona | 85016 | United States | ||
| Beverly Hills Cancer Center |
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
A total of 126 participants with relapsed or refractory follicular lymphoma were enrolled in the study and assigned to one of two treatment groups: Treatment A or Treatment B to receive parsaclisib.
Participants took part in the study at 44 investigative sites in the United States, Italy, Spain, Great Britain, Czech Republic, Hungary, Canada, Denmark, Germany, Israel, Poland, and Sweden
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW | Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. |
| FG001 | Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD |
| 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 | Dec 23, 2019 | Jan 12, 2022 |
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|
| Up to 1193 days |
| Duration of Response (DOR) | DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions. | Up to 1193 days |
| Progression-free Survival (PFS) With Parsaclisib | PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. | Up to 1193 days |
| Overall Survival (OS) With Parsaclisib | OS was defined as the time from the date of the first dose of study treatment until death from any cause. | Up to 1193 days |
| Best Percent Change From Baseline in Target Lesion Size | Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement. | Up to 1193 days |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention. | up to approximately 1992 days |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Synergy Hematology and Oncology Medical Associates | Los Angeles | California | 90036 | United States |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| American Institute of Research Corporate Office | Whittier | California | 90603 | United States |
| Cancer Center of Central Connecticut | Southington | Connecticut | 06489 | United States |
| Florida Cancer Specialists & Research Institute | Fort Myers | Florida | 33901 | United States |
| Asclepes Research Centers | Spring Hill | Florida | 34606 | United States |
| Clinical Trials of Swla Llc | Lake Charles | Louisiana | 70601 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| Barbara Ann Karmanos Cancer Hospital | Detroit | Michigan | 48201 | United States |
| Hattiesburg Clinic Hematology | Hattiesburg | Mississippi | 39401 | United States |
| Saint Luke'S Hospital | Kansas City | Missouri | 64111 | United States |
| Sarah Cannon Research Institute | Kansas City | Missouri | 64132 | United States |
| Clinical Research Alliance, Inc. | New Hyde Park | New York | 11042 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Charleston Hematology Oncology Associates Pa | Charleston | South Carolina | 29414 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Renovatio Clinical Consultants Llc | Spring | Texas | 77380 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Western Health | St Albans | Victoria | 03021 | Australia |
| Border Medical Oncology | Wodonga | Victoria | 03690 | Australia |
| St Vincent'S Hospital Sydney | Darlinghurst | 02010 | Australia |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Santa Cabrini Hospital | Montreal | Quebec | H1T 1P7 | Canada |
| University Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni Nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| University Hospital Kralovkse Vinohrady | Prague | 10034 | Czechia |
| Univerzita Karlova V Praze 1. Lekarska Fakulta | Prague | 120 0 | Czechia |
| Fakultni Nemocnice V Motole | Prague | 15000 | Czechia |
| Aalborg University Hospital | Aalborg | 09000 | Denmark |
| Odense Universitetshospital (Ouh) (Odense University Hospital) | Odense C | 05000 | Denmark |
| Bag Arnoldstr. Dresden | Dresden | 01307 | Germany |
| University Medical Center Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Mainz | 55131 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| Semmelweis Egyetem | Budapest | 01085 | Hungary |
| National Institute of Oncology | Budapest | 01122 | Hungary |
| University of Debrecen | Debrecen | 04032 | Hungary |
| Somogy Medyei Kaposi Mor Oktato Korhaz | Kaposvár | 07400 | Hungary |
| Hillel Yafe Medical Center (Hymc) | Hadera | 38100 | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Laniado Hospital Hematology | Netanya | 42150 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Irccs Centro Di Riferimento Oncologico | Aviano | 33081 | Italy |
| Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari | Bari | 70124 | Italy |
| University of Bologna | Bologna | 40126 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori | Meldola | 47014 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| A.O.U. Di Modena - Policlinico | Modena | 41124 | Italy |
| A.O.U. Federico Ii | Naples | 80131 | Italy |
| Aou Maggiore Della Carita | Novara | 28100 | Italy |
| Ospedali Riuniti Villa Sofia Cervello | Palermo | 90146 | Italy |
| Sapienza University | Rome | 00161 | Italy |
| I.R.C.C.S. Casa Sollievo Della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| Aou Citta Della Salute E Della Scienza Di Torino | Torino | 10126 | Italy |
| San Bartolo Hospital | Vicenza | 36100 | Italy |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Pratia McM Krakow | Krakow | 30-510 | Poland |
| State Hospital Opole | Opole | 45-372 | Poland |
| Institute of Hematology and Transfusion Medicine | Warsaw | 02-776 | Poland |
| Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08026 | Spain |
| Hospital General Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Hgu Gregorio Maranon | Madrid | 28009 | Spain |
| Md Anderson Cancer Centre Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Hm Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Quironsalud Madrid | Madrid | 28223 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41007 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Karolinska University Hospital, Huddinge | Stockholm | 14141 | Sweden |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Northwick Park Hospital | London | SE5 9RS | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| The Royal Marsden Nhs Foundation Trust - Chelsea | Sutton | SM2 5PT | United Kingdom |
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW | Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. |
| BG001 | Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD | Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race Customized | Count of Participants | Participants |
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| 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 | Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria | ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 148 weeks |
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| Secondary | Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria | CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1193 days |
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| Secondary | Duration of Response (DOR) | DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1193 days |
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| Secondary | Progression-free Survival (PFS) With Parsaclisib | PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Median | 95% Confidence Interval | months | Up to 1193 days |
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| Secondary | Overall Survival (OS) With Parsaclisib | OS was defined as the time from the date of the first dose of study treatment until death from any cause. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Median | 95% Confidence Interval | months | Up to 1193 days |
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| Secondary | Best Percent Change From Baseline in Target Lesion Size | Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. The overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | percent change in lesion size | Up to 1193 days |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention. | Safety Population: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Number | percentage of participants | up to approximately 1992 days |
|
up to approximately 1992 days
Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study who received at least 1 dose of parsaclisib.
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 | Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW | Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. | 5 | 23 | 12 | 23 | 22 | 23 |
| EG001 | Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD | Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. | 27 | 103 | 55 | 103 | 94 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Autoimmune arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Campylobacter colitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Colitis erosive | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Desmoplastic mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | 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 | Jan 28, 2021 | Jan 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656179 | parsaclisib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/ African- American |
|
| White/ Caucasian |
|
| Unavailable or Unknown |
|
| Participants |
|
|
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
|
|