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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765FLR3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-003093-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.
This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 400 adult participants with follicular lymphoma or marginal zone lymphoma. The study will include the following phases: Screening, Treatment, and a Post-treatment Follow-up. Eligible participants will be randomly assigned in a 1:1 ratio to either treatment Arm A (background immune-chemotherapy + placebo) or treatment Arm B (background immune-chemotherapy + 560 milligram [mg] of ibrutinib). All participants will receive 6 cycles of background immune-chemotherapy with either BR or R-CHOP in combination with either placebo (Arm A) or ibrutinib (Arm B). Selection of background immune-chemotherapy will be based on prior treatment history and cardiac function. After completion of background immune-chemotherapy, study drug (ibrutinib or placebo) will continue until disease progression, unacceptable toxicity, or study end, whichever comes first. Assessment of tumor response and progression will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Safety will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Placebo Comparator | Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo. |
|
| Treatment Arm B | Experimental | Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | 90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Up to 8 years |
| Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Analysis: Overall Survival (OS): Stratified Analysis | OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37722354 | Derived | Nastoupil LJ, Hess G, Pavlovsky MA, Danielewicz I, Freeman J, Garcia-Sancho AM, Glazunova V, Grigg A, Hou JZ, Janssens A, Kim SJ, Masliak Z, McKay P, Merli F, Munakata W, Nagai H, Ozcan M, Preis M, Wang T, Rowe M, Tamegnon M, Qin R, Henninger T, Curtis M, Caces DB, Thieblemont C, Salles G. Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma. Blood Adv. 2023 Nov 28;7(22):7141-7150. doi: 10.1182/bloodadvances.2023010298. |
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Placebo+CIT arm participants discontinued the study treatment post the primary analysis but were assessed for the safety till the end of the study. No further efficacy analyses were done after the primary analysis.
Participants were stratified by background chemotherapy treatment (bendamustine and rituximab [BR] or combination or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]), refractory versus relapsed disease, Indolent non-Hodgkin lymphoma histology, and number of prior lines of therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Chemoimmunotherapy (CIT) | Participants received 4 capsules of placebo matching to ibrutinib orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 milligrams per meter square (mg/m^2) intravenously (IV) on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Placebo + CIT" discontinued placebo treatment. |
| 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 | Aug 29, 2022 | Mar 23, 2023 |
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| Rituximab | Drug | 375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. |
|
| Cyclophosphamide | Drug | 750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. |
|
| Doxorubicin | Drug | 50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. |
|
| Vincristine | Drug | 1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6. |
|
| Prednisone | Drug | 100 mg administered orally on Days 1 to 5 of Cycles 1 to 6. |
|
| PCI-32765 (Ibrutinib) | Drug | 560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1. |
|
| Placebo | Drug | Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1. |
|
| Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL |
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
| Up to 8 years |
| Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Up to 8 years |
| Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL | CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | Up to 8 years |
| Primary Analysis: Overall Response Rate (ORR): Stratified Analysis | ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Up to 8 years |
| Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL | ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | Up to 8 years |
| Primary Analysis: Duration of Response (DOR): Stratified Analysis | DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Up to 8 years |
| Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL | DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | Up to 8 years |
| Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire | Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. | Up to 8 years |
| Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL | TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. | Up to 8 years |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. | Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months) |
| Number of Participants With TEAEs: Participants With MZL | Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. | Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months) |
| Campbell |
| California |
| United States |
| Duarte | California | United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| Orange | California | United States |
| Ocala | Florida | United States |
| Chicago | Illinois | United States |
| Maywood | Illinois | United States |
| Indianapolis | Indiana | United States |
| Westwood | Kansas | United States |
| Lexington | Kentucky | United States |
| Lafayette | Louisiana | United States |
| Scarborough | Maine | United States |
| Baltimore | Maryland | United States |
| Bethesda | Maryland | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Battle Creek | Michigan | United States |
| Detroit | Michigan | United States |
| Saint Louis Park | Minnesota | United States |
| Denville | New Jersey | United States |
| New York | New York | United States |
| Hickory | North Carolina | United States |
| Pinehurst | North Carolina | United States |
| Bend | Oregon | United States |
| Pittsburgh | Pennsylvania | United States |
| Sioux Falls | South Dakota | United States |
| Houston | Texas | United States |
| Lubbock | Texas | United States |
| Spokane | Washington | United States |
| Green Bay | Wisconsin | United States |
| Buenos Aires | Argentina |
| Ciudad Autonoma Buenos Aires | Argentina |
| Córdoba | Argentina |
| La Capital | Argentina |
| Mendoza | Argentina |
| Santa Fe | Argentina |
| Adelaide | Australia |
| Fitzroy | Australia |
| Heidelberg | Australia |
| South Brisbane | Australia |
| Wahroonga | Australia |
| Westmead | Australia |
| Anderlecht | Belgium |
| Edegem | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Namur | Belgium |
| Wilrijk | Belgium |
| Porto Alegre | Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Beijing | China |
| Chengdu | China |
| Guangzhou | China |
| Hangzhou | China |
| Harbin | China |
| Nanjing | China |
| Shanghai | China |
| Tianjin | China |
| Nice | France |
| Paris | France |
| Pessac | France |
| Pierre-Bénite | France |
| Rennes | France |
| Berlin | Germany |
| Giessen | Germany |
| Göttingen | Germany |
| Ludwigshafen | Germany |
| Magdeburg | Germany |
| Mainz | Germany |
| München | Germany |
| Wiesbaden | Germany |
| Hadera | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Nahariya | Israel |
| Netanya | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Chūōku | Japan |
| Hiroshima | Japan |
| Isehara | Japan |
| Kobe | Japan |
| Nagoya | Japan |
| Osaka Sayama Shi | Japan |
| Sapporo | Japan |
| Sendai | Japan |
| Suita-shi | Japan |
| Tokyo | Japan |
| Gdynia | Poland |
| Olsztyn | Poland |
| Warsaw | Poland |
| Bayamón | Puerto Rico |
| Ponce | Puerto Rico |
| San Juan | Puerto Rico |
| Krasnodar | Russia |
| Moscow | Russia |
| Nizny Novgorod | Russia |
| Petrozavodsk | Russia |
| Pyatigorsk | Russia |
| Rostov-on-Don | Russia |
| Saint Petersburg | Russia |
| Syktyvkar | Russia |
| Volgograd | Russia |
| Jeollanam-do | South Korea |
| Seoul | South Korea |
| Barcelona | Spain |
| Madrid | Spain |
| Pozuelo de Alarcón | Spain |
| Salamanca | Spain |
| Gothenburg | Sweden |
| Linköping | Sweden |
| Luleå | Sweden |
| Uppsala | Sweden |
| Ankara | Turkey (Türkiye) |
| Antalya | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Kayseri | Turkey (Türkiye) |
| Cherkasy | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Khmelnitskiy | Ukraine |
| Kiev | Ukraine |
| Lviv | Ukraine |
| Uzhhorod | Ukraine |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Plymouth | United Kingdom |
| Portsmouth | United Kingdom |
| Sutton | United Kingdom |
| Swansea | United Kingdom |
| FG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
| Safety Analysis Set |
|
| Participants With Marginal Zone Lymphoma (MZL) |
|
| Participants With Follicular Lymphoma (FL) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Chemoimmunotherapy (CIT) | Participants received 4 capsules of placebo matching to ibrutinib orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 milligrams per meter square (mg/m^2) intravenously (IV) on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Placebo + CIT" discontinued placebo treatment. |
| BG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | Intent-to-treat (ITT) population included all randomized participants who were enrolled with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Primary | Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Primary Analysis: Overall Survival (OS): Stratified Analysis | OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL | OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | Posted | Number | percentage of participants | Up to 8 years |
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| Secondary | Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL | CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | Posted | Number | percentage of participants | Up to 8 years |
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| Secondary | Primary Analysis: Overall Response Rate (ORR): Stratified Analysis | ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | Posted | Number | percentage of participants | Up to 8 years |
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| Secondary | Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL | ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | Posted | Number | percentage of participants | Up to 8 years |
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| Secondary | Primary Analysis: Duration of Response (DOR): Stratified Analysis | DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. Participants who achieved a PR or better were included in the analysis of duration of response. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL | DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. Participants who achieved a PR or better were included in the analysis of duration of response. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire | Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL | TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. | Safety analysis population included all randomized participants who received at least 1 dose of study drug, and were analyzed according to the actual treatment received. | Posted | Count of Participants | Participants | Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months) |
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| Secondary | Number of Participants With TEAEs: Participants With MZL | Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. | Safety analysis population included all randomized participants with MZL who received at least 1 dose of study drug, and were analyzed according to the actual treatment received. | Posted | Count of Participants | Participants | Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years 8 months) |
|
All Serious AEs and Other (Not Including Serious) AEs: for Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after last dose of study medication (up to 8 years 8 months); all cause mortality: From Day 1 up to end of study (up to 9 years 1 month)
All reported serious AEs and other AEs were analyzed on safety population: all randomized participants who received at least 1 dose of study drug, and were analyzed according to actual treatment received. All-cause mortality: ITT population - all randomized participants who were enrolled with FL/MZL and were analyzed according to treatment to which they were randomized. Placebo+CIT arm participants discontinued study treatment post primary analysis but were assessed for safety till end of study.
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 | Placebo + Chemoimmunotherapy (CIT) | Participants received 4 capsules of placebo matching to ibrutinib orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 milligrams per meter square (mg/m^2) intravenously (IV) on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Placebo + CIT" discontinued placebo treatment. | 61 | 201 | 76 | 199 | 196 | 199 |
| EG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. | 65 | 202 | 113 | 201 | 198 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aortic Valve Incompetence | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Dysfunction | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Failure Chronic | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ear Discomfort | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tympanic Membrane Perforation | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cataract Cortical | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Necrotising Retinitis | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anal Incontinence | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenic Colitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancreatitis Chronic | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pharyngo-Oesophageal Diverticulum | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rectal Stenosis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Metaplasia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pelvic Mass | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspergillus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Campylobacter Gastroenteritis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Chorioretinitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Escherichia Pyelonephritis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemophilus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Intervertebral Discitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pelvic Abscess | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia Cytomegaloviral | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia Herpes Viral | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia Klebsiella | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulpitis Dental | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Salmonella Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Skin Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vascular Device Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vestibular Neuronitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypopharyngeal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasal Cavity Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Small Cell Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of the Tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Post Herpetic Neuralgia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Disinhibition | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Psychiatric Decompensation | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cystitis Noninfective | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Obstructive Nephropathy | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pelvi-Ureteric Obstruction | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Uterine Cyst | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vocal Cord Leukoplakia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vocal Cord Polyp | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Extremity Necrosis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medial Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2022 | Mar 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| 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 |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| C551803 | ibrutinib |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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 |
|
| AUSTRALIA |
|
| BELGIUM |
|
| BRAZIL |
|
| CHINA |
|
| FRANCE |
|
| GERMANY |
|
| ISRAEL |
|
| ITALY |
|
| JAPAN |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TURKEY |
|
| UKRAINE |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
|
|
|
Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
|
|
| Ibrutinib + CIT |
Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
|
|
| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
|
|
| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
|
|
| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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| OG001 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m^2 IV on Day 1, cyclophosphamide 750 mg/m^2 IV on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm "Ibrutinib + CIT" continued/stopped treatment with ibrutinib at the discretion of the treating physician. |
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