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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004008-20 | EudraCT Number |
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This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).
This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT.
Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.
After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response [CR] or partial response [PR]) or stable disease according to the International Working Group criteria by the end of Cycle 13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvelisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvelisib | Drug | Phosphoinositide-3-kinase (PI3K) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval. | Every 8-16 weeks while on treatment with duvelisib for up to 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095-6984 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30742566 | Derived | Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. |
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This multicenter, multinational study enrolled participants at 56 medical clinics across 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duvelisib | Participants received a dose of 25 milligrams (mg) duvelisib twice daily (BID) over the course of 28-day treatment cycles until disease progression or unacceptable toxicity. |
| 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 | Nov 3, 2015 | Feb 9, 2023 |
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| Every 2-8 weeks for up to 73 months |
| Duration of Response (DOR) | DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Every 8-16 weeks for up to 72 months |
| Progression-free Survival (PFS) | PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Every 8-16 weeks for up to 72 months |
| Overall Survival (OS) | OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Every 16 weeks for up to 72 months |
| Plasma Concentration of Duvelisib and IPI-656 | The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL). | Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit) |
| Time to Response (TTR) | TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee [IRC]) according to the revised IWG Response Criteria for Malignant Lymphoma. | First dose to first documentation of complete or partial response (up to 6 months) |
| Whittier |
| California |
| 90603 |
| United States |
| Denver | Colorado | 80218 | United States |
| Fort Myers | Florida | 39916 | United States |
| St. Petersburg | Florida | 33705 | United States |
| Tallahassee | Florida | 32308 | United States |
| Atlanta | Georgia | 30322 | United States |
| Chicago | Illinois | 60637 | United States |
| Louisville | Kentucky | 40207 | United States |
| Baltimore | Maryland | 21204 | United States |
| Baltimore | Maryland | 21229 | United States |
| Boston | Massachusetts | 02215 | United States |
| St Louis | Missouri | 63110 | United States |
| Howell Township | New Jersey | 07731 | United States |
| Morristown | New Jersey | 07962 | United States |
| New York | New York | 10021 | United States |
| Rockville Centre | New York | 11510 | United States |
| Canton | Ohio | 44718 | United States |
| Lawton | Oklahoma | 73505 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Philadelphia | Pennsylvania | 01911 | United States |
| Nashville | Tennessee | 37203 | United States |
| Dallas | Texas | 75246 | United States |
| Lynchburg | Virginia | 24501 | United States |
| Lyasny | Minsk Oblast | 223040 | Belarus |
| Brest | 224027 | Belarus |
| Minsk | 220013 | Belarus |
| Vitebsk | 210603 | Belarus |
| Ghent | 9000 | Belgium |
| Kortrijk | 8500 | Belgium |
| Sofia | 1233 | Bulgaria |
| Sofia | 1407 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Toronto | Ontario | M5G 2M9 | Canada |
| Gatineau | Quebec | J8P7H2 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Brno | 625-00 | Czechia |
| Ostrava-Poruba | 708-52 | Czechia |
| Angers | 49933 | France |
| Bordeaux | 33076 | France |
| Clermont-Ferrand | 63000 | France |
| Marseille | 13005 | France |
| Pierre-Bénite | 69495 | France |
| Tbilisi | 0186 | Georgia |
| Budapest | 1083 | Hungary |
| Budapest | 1122 | Hungary |
| Debrecen | 4032 | Hungary |
| Bologna | 40138 | Italy |
| Brescia | 25123 | Italy |
| Busto Arsizio | 21052 | Italy |
| Genova | 16132 | Italy |
| Meldola | 47014 | Italy |
| Milan | 20162 | Italy |
| Modena | 41124 | Italy |
| Orbassano | 10043 | Italy |
| Parma | 43100 | Italy |
| Ravenna | 48121 | Italy |
| Rimini | 47923 | Italy |
| Varese | 21100 | Italy |
| Barcelona | 08036 | Spain |
| Madrid | 28222 | Spain |
| Salamanca | 37007 | Spain |
| Cardiff | CF 14 4XW | United Kingdom |
| Chelsea | United Kingdom |
| Liverpool | L7 8XP | United Kingdom |
| London | NW1 2PG | United Kingdom |
| London | W1G 6AD | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duvelisib | Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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) | ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 8-16 weeks while on treatment with duvelisib for up to 72 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Posted | Count of Participants | Participants | Every 2-8 weeks for up to 73 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Posted | Median | 95% Confidence Interval | months | Every 8-16 weeks for up to 72 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Posted | Median | 95% Confidence Interval | months | Every 8-16 weeks for up to 72 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib. | Posted | Median | 95% Confidence Interval | months | Every 16 weeks for up to 72 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Duvelisib and IPI-656 | The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL). | Pharmacokinetics (PK) Set: all participants who received at least 1 dose of duvelisib and with at least 1 adequate post-baseline blood sample. | Posted | Median | Full Range | ng/mL | Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee [IRC]) according to the revised IWG Response Criteria for Malignant Lymphoma. | Full Analysis Set (FAS): all participants who received at least 1 dose of duvelisib and who were considered responders (CR or PR) per IRC. | Posted | Median | Inter-Quartile Range | month | First dose to first documentation of complete or partial response (up to 6 months) |
|
|
73 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duvelisib | Participants received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity. | 68 | 129 | 83 | 129 | 122 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cystitis pseudomonal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment | This adverse event only affected male participants. |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Vulval cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment | This adverse event only affected female participants. |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia moraxella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Gregory, PharmD, MBA | Secura Bio, Inc. | 1-702-254-0011 | bgregory@securabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2016 | Feb 9, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C586691 | duvelisib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Other |
|
| Unknown |
|
| Missing |
|
| Czechia |
|
| United Kingdom |
|
| Belarus |
|
| Spain |
|
| Canada |
|
| Belgium |
|
| Italy |
|
| Georgia |
|
| France |
|
| Bulgaria |
|
|
|
|
|
|
|