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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001381-14 | EudraCT Number |
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This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvelisib, Continuous and Intermittent Dosing | Experimental | Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle. |
|
| Duvelisib, Intermittent Dosing | Experimental | Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvelisib | Drug | Phosphoinositide 3-kinase (PI3K) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria | ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. | Up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography [PET-CT]) and progressive disease (according to computed tomography [CT]). Results reported as months. |
Not provided
Inclusion Criteria:
Eastern Cooperative Oncology Group performance status ≤ 2
Histologically confirmed diagnosis of iNHL (subtypes include follicular lymphoma [FL] Grades 1 to 3a), marginal zone lymphoma (splenic, nodal, or extranodal), or small lymphocytic lymphoma
Must have received 1 prior systemic regimen for iNHL
Must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 centimeters (which has not been previously irradiated), according to 2007 revised International Working Group criteria, and be a candidate for a subsequent line of therapy.
Must have adequate organ function defined by the following laboratory parameters:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists - Fort Myers | Fort Myers | Florida | 33901 | United States | ||
| Florida Cancer Specialists & Research Institute - Lecanto |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duvelisib, Continuous and Intermittent Dosing | Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle. |
| FG001 | Duvelisib, Intermittent Dosing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | Jul 23, 2024 |
Not provided
Not provided
Not provided
Not provided
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| Up to 2 years |
| ORR At Specific Timepoints | ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint. | 6, 12, 18, and 24 months after first dose of study intervention |
| Duration of Response (DOR) | DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months. | Up to 2 years |
| Overall Survival (OS) | OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months. | Up to 2 years |
| Lymph Node Response Rate (LNRR) | LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis. | 14 months |
| Time To First Response (TTFR) | For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months. | Up to 14 months |
| Time To Treatment Failure (TTF) | TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months. | Up to 2 years |
| ORR According to 2014 Lugano Criteria | ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). | Up to 14 months |
| Lecanto |
| Florida |
| 34461 |
| United States |
| Mid-Florida Cancer Centers | Orange City | Florida | 32763 | United States |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| FN Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Universitaetsklinikum Bonn AöR | Bonn | 53127 | Germany |
| Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori | Meldola | Forli | 47014 | Italy |
| IEO - Istituto Europeo di Oncologia, IRCCS | Milan | 20141 | Italy |
| AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| Azienda Ospedaliera Santa Maria di Terni | Terni | 05100 | Italy |
| Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o. | SÅ‚upsk | Pomeranian Voivodeship | 76-200 | Poland |
| Pratia Onkologia Katowice | Katowice | 40-519 | Poland |
| Centrum Medyczne Pratia Poznan | Skórzewo | 60-185 | Poland |
| State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City | Moscow | 108814 | Russia |
| City Clinical Hospital n.a. Botkin | Moscow | 125284 | Russia |
| First Saint-Petersburg State Medical University n.a. I.P. Pavlov | Saint Petersburg | 197022 | Russia |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center - Oncology | Seoul | 05505 | South Korea |
| Samsung Medical Center - Hematology-Oncology | Seoul | 06351 | South Korea |
| NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit | Glasgow | G12 0YN | United Kingdom |
| Royal Liverpool Hospital [Hematology/Transfusion Medicine] | Liverpool | L7 8XP | United Kingdom |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. |
| Received At Least 1 Dose of Study Drug | All-treated (AT) Analysis Set/Modified Intent-to-treat (mITT) Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All-Treated (AT) Analysis Set: All participants who receive at least 1 dose of duvelisib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duvelisib, Continuous and Intermittent Dosing | Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle. |
| BG001 | Duvelisib, Intermittent Dosing | Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria | ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 14 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography [PET-CT]) and progressive disease (according to computed tomography [CT]). Results reported as months. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | ORR At Specific Timepoints | ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 6, 12, 18, and 24 months after first dose of study intervention |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Lymph Node Response Rate (LNRR) | LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 14 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time To First Response (TTFR) | For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | months | Up to 14 months |
| ||||||||||||||||||||||||||||||
| Secondary | Time To Treatment Failure (TTF) | TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months. | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | ORR According to 2014 Lugano Criteria | ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). | Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 14 months |
|
|
Up to 37 months
All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.
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 | Duvelisib, Continuous and Intermittent Dosing | Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle. | 8 | 51 | 13 | 51 | 49 | 51 |
| EG001 | Duvelisib, Intermittent Dosing | Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off. | 7 | 51 | 16 | 51 | 50 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pylorospasm | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ohad Bentur, MD, MHA, MSc | Secura Bio, Inc. | 1-702-254-0011 | obentur@securabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2023 | Jul 23, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C586691 | duvelisib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PP |
|
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