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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003893-29 | EudraCT Number |
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The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copanlisib + Rituximab | Experimental | Combination of the Copanlisib and rituximab |
|
| Placebo + Rituximab | Placebo Comparator | Combination of Copanlisib placebo and rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Drug | Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Based on Independent Central Review. | Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). | From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percentage of participants who have a best response rating over the whole duration of the study (i.e. until time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria (kindly refer to the links in the Protocol section). |
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Inclusion Criteria:
Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients, with histological subtype limited to:
Patients must have relapsed (recurrence after complete response or presented progression after partial response) after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing therapy (other previous treatment lines after rituximab are allowed). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy is allowed for patients who responded to single-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible.
Non-WM must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL (Marginal-zone lymphoma) this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal (ULN) and positive immunofixation test .
Male or female patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Life expectancy of at least 3 months
Availability of fresh tumor tissue and/or archival tumor tissue for central pathology(obtained within 5 years of the consent date) at Screening
Adequate baseline laboratory values collected no more than 7 days before starting study treatment
Left ventricular ejection fraction ≥ 45%
Patients must either:
have had a progression-free and treatment-free interval of at least 12 months after completion of the rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment OR
be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features:
Age ≥ 80 years
Age < 80 years and at least 1 of the following conditions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Covina | California | 91790 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33848462 | Result | Matasar MJ, Capra M, Ozcan M, Lv F, Li W, Yanez E, Sapunarova K, Lin T, Jin J, Jurczak W, Hamed A, Wang MC, Baker R, Bondarenko I, Zhang Q, Feng J, Geissler K, Lazaroiu M, Saydam G, Szomor A, Bouabdallah K, Galiulin R, Uchida T, Soler LM, Cao A, Hiemeyer F, Mehra A, Childs BH, Shi Y, Zinzani PL. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. doi: 10.1016/S1470-2045(21)00145-5. Epub 2021 Apr 10. | |
| 38226495 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer AG products conducted in Europe. | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Overall, 652 were screened and total of 458 participants were randomized in a 2:1 ratio to study treatment: 307 participants to copanlisib/rituximab and 151 participants to placebo/rituximab.
The study was conducted at multiple centers in North America, South America, South Africa, Europe, Asia, and Australia between 03 August 2015 (first participant first visit) and 15 November 2024 (last participant first visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Copanlisib + Rituximab | Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab. |
| FG001 |
| 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 | Feb 9, 2023 | Aug 18, 2025 |
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|
| Placebo | Drug | Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab. |
|
| Rituximab | Drug | Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water. |
|
| From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Complete Response Rate (CRR) | Complete response rate (CRR) was defined as the percentage of participants who had a best response rating over the whole duration of the study (i.e., until the time of analysis of PFS) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of Complete Response according to the Owen Criteria (kindly refer to the links in the Protocol section). | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Duration of Response (DOR) | Duration of response (DOR) was defined as the time (in days) from first observed tumor response Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) or Minor Response (MR) until progression or death from any cause, whichever occurred earlier according to the Owen Criteria (kindly refer to the links in the Protocol section). Only patients with response in FAS were included in the analysis. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Disease Control Rate (DCR) | Disease control rate was defined as the percentage of participants who had a best response rating as Complete Response (CR), Partial Response (PR) or stable disease (SD) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) as a response rating of CR, very good partial response (VGPR), PR, minor response (MR) or stable disease (SD) according to the Owen Criteria (kindly refer to the links in the Protocol section). | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Time to Progression (TTP) | Time to progression (TTP) was defined as the time (days) from date of randomization to date of first observed disease progression according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Overall Survival (OS) | Overall survival was defined as the time (in days) from randomization until death from any cause. | From randomization up to the final analysis at 15-Nov-2024 up to 9 years |
| Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | Time to deterioration in DRS-P (Disease-Related Symptoms - Physical) of at least three points was defined as the time (in days) from randomization to DRS-P decline, progression, or death due to any reason, whichever occurred earlier. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | Time to improvement in DRS-P (Disease-Related Symptoms - Physical) was defined as the time (in days) from randomization to DRS-P improvement of at least three points. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date. | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date. | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Up to 30 days after end of treatment with study drug, data reporting cut-off at 7 years from the first participant randomization date |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Up to 30 days after end of treatment with study drug, data reporting cut-off at final analysis, up to 9 years |
| Ashland |
| Kentucky |
| 41101 |
| United States |
| Louisville | Kentucky | 40207 | United States |
| Bethesda | Maryland | 20817 | United States |
| Las Vegas | Nevada | 89169 | United States |
| Montvale | New Jersey | 07645 | United States |
| MSK Basking Ridge | New Jersey | New Jersey | United States |
| MSK Bergen | New Jersey | New Jersey | United States |
| MSK Monmoth | New Jersey | New Jersey | United States |
| MSK Westchester | Harrison | New York | United States |
| MSK Commack | Long Island City | New York | United States |
| MSK Rockville Centre | Long Island City | New York | United States |
| New York | New York | 10065 | United States |
| Canton | Ohio | 44718 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Spokane | Washington | 99208 | United States |
| Buenos Aires | Ciudad Auton. de Buenos Aires | TBC | Argentina |
| Rosario | Santa Fe Province | S2000DEJ | Argentina |
| San Miguel de Tucumán | Tucumán Province | T4000 | Argentina |
| Córdoba | X5000AOQ | Argentina |
| Ballarat | Victoria | 3350 | Australia |
| Nedlands | 6009 | Australia |
| Graz | Styria | 8036 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1130 | Austria |
| Ottignies | 1340 | Belgium |
| Passo Fundo | Rio Grande do Sul | 99020-240 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90850-170 | Brazil |
| Barretos/SP | São Paulo | 14784-400 | Brazil |
| Jaú | São Paulo | 17210-120 | Brazil |
| São Paulo | São Paulo | 01234-030 | Brazil |
| São Paulo | São Paulo | 08270-070 | Brazil |
| São Paulo | 05403-000 | Brazil |
| São Paulo | 05651-901 | Brazil |
| Plovdiv | 4000 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Temuco | Araucania | 4800827 | Chile |
| Fuzhou | Fujian | 350000 | China |
| Guangzhou | Guangdong | 510000 | China |
| Guangzhou | Guangdong | TBC | China |
| Wuhan | Hubei | 430079 | China |
| Nanjing | Jiangsu | 210000 | China |
| Suzhou | Jiangsu | 215000 | China |
| Nanchang | Jiangxi | 330029 | China |
| Changchun | Jilin | 130061 | China |
| Shengyang | Liaoning | 110042 | China |
| Chengdu | Sichuan | 610041 | China |
| Ürümqi | Xinjiang | 830011 | China |
| Hangzhou | Zhejiang | 310000 | China |
| Hangzhou | Zhejiang | 310022 | China |
| Beijing | 100000 | China |
| Beijing | 100050 | China |
| Beijing | 100083 | China |
| Beijing | 100730 | China |
| Chongqing | 400030 | China |
| Chongqing | 400042 | China |
| Shanghai | 200000 | China |
| Shanghai | 200025 | China |
| Shanghai | 200032 | China |
| Tianjin | 300000 | China |
| Tianjin | 300121 | China |
| Medellín | Antioquia | 050034 | Colombia |
| Bogota | Cundinamarca | 111511 | Colombia |
| Montería | Departamento de Córdoba | 230002 | Colombia |
| Cali | Valle del Cauca Department | 760032 | Colombia |
| Bayonne | 64100 | France |
| Brest | 29470 | France |
| Metz | 57085 | France |
| Nice | 6189 | France |
| Pessac | 33600 | France |
| Poitiers | 86021 | France |
| Saint-Herblain | 44800 | France |
| München | Bavaria | 81377 | Germany |
| Recklinghausen | North Rhine-Westphalia | 45659 | Germany |
| Dresden | Saxony | 1307 | Germany |
| Halle | Saxony-Anhalt | 6120 | Germany |
| Berlin | 10967 | Germany |
| Athens | 106 76 | Greece |
| Athens | 11527 | Greece |
| Chaïdári | 12462 | Greece |
| Pátrai | 26500 | Greece |
| Chai Wan | 0 | Hong Kong |
| Hong Kong | MISSING | Hong Kong |
| Budapest | 1083 | Hungary |
| Győr | 9024 | Hungary |
| Kaposvár | 7400 | Hungary |
| Pécs | 7623 | Hungary |
| Tatabánya | 2800 | Hungary |
| Dublin | D07R2WY | Ireland |
| Dublin | D08NHY1 | Ireland |
| Galway | H91YR71 | Ireland |
| Udine | Friuli Venezia Giulia | 33038 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Milan | Lombardy | 20133 | Italy |
| Florence | Tuscany | 50134 | Italy |
| Nagoya | Aichi-ken | 464-8681 | Japan |
| Nagoya | Aichi-ken | 466-8650 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Kobe | Hyōgo | 650-0047 | Japan |
| Nankoku | Kochi | 783-8505 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Ōmura | Nagasaki | 856-8562 | Japan |
| Kurashiki | Okayama-ken | 710-8602 | Japan |
| Hirakata | Osaka | 573-1191 | Japan |
| Izumo | Shimane | 693-8501 | Japan |
| Chuo-ku | Tokyo | 104-0045 | Japan |
| Aomori | 030-8553 | Japan |
| Fukuoka | 811-1395 | Japan |
| Kumamoto | 860-8556 | Japan |
| Niigata | 951-8566 | Japan |
| Osaka | 545-8586 | Japan |
| Yamagata | 990-9585 | Japan |
| Kaunas | LT-50009 | Lithuania |
| Cheras | 56000 | Malaysia |
| Kota Kinabalu | 88586 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Kuala Selangor | 68000 | Malaysia |
| Perak | 30450 | Malaysia |
| Pulau Pinang | 10450 | Malaysia |
| Morelia | Michoacán | 58260 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| Tauranga | 3112 | New Zealand |
| City of Taguig | 1102 | Philippines |
| Pasig | 1605 | Philippines |
| Gdansk | 80-214 | Poland |
| Gdynia | 81-519 | Poland |
| Krakow | 30-727 | Poland |
| Lublin | 20-090 | Poland |
| Porto | 4200-072 | Portugal |
| Porto | 4434-502 | Portugal |
| Brasov | 500152 | Romania |
| Bucharest | 10825 | Romania |
| Bucharest | 20125 | Romania |
| Bucharest | 22328 | Romania |
| Bucharest | 30171 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Craiova | 200143 | Romania |
| Târgu Mureş | 540136 | Romania |
| Chelyabinsk | 454048 | Russia |
| Irkutsk | 664035 | Russia |
| Kazan' | 420029 | Russia |
| Kemerovo | 650066 | Russia |
| Kirov | 610027 | Russia |
| Novosibirsk | 630087 | Russia |
| Omsk | 644013 | Russia |
| Saint Petersburg | 197022 | Russia |
| Volgograd | 400138 | Russia |
| Singapore | 119074 | Singapore |
| Singapore | 168583 | Singapore |
| Singapore | 169608 | Singapore |
| Poprad | 058 01 | Slovakia |
| George | Eastern Cape | 6530 | South Africa |
| Johannesburg | Gauteng | 2013 | South Africa |
| Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Seoul | Seoul Teugbyeolsi | 3080 | South Korea |
| Busan | 49201 | South Korea |
| Busan | 49241 | South Korea |
| Hwasun Gun | 58128 | South Korea |
| Seoul | 06351 | South Korea |
| Majadahonda | Madrid | 28222 | Spain |
| Málaga | Málaga | 20910 | Spain |
| Barcelona | 08003 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 8041 | Spain |
| Madrid | 28041 | Spain |
| Salamanca | 37007 | Spain |
| Changhua | 50006 | Taiwan |
| Kaohsiung City | 833 | Taiwan |
| Tainan | 704 | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 11217 | Taiwan |
| Chiang Mai | 50200 | Thailand |
| Pathum Thani | 10120 | Thailand |
| Ankara | 6100 | Turkey (Türkiye) |
| Istanbul | 34093 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Kayseri | 38039 | Turkey (Türkiye) |
| Trabzon | 61080 | Turkey (Türkiye) |
| Cherkasy | 18009 | Ukraine |
| Dnipro | 49102 | Ukraine |
| Kyiv | 03022 | Ukraine |
| Lviv | 79044 | Ukraine |
| Vinnitsa | 21029 | Ukraine |
| Hà Nội | 10000 | Vietnam |
| Ho Chi Minh City | 70000 | Vietnam |
| Derived |
| Morcos PN, Moss J, Veasy J, Hiemeyer F, Childs BH, Garmann D. Model-Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen. Clin Pharmacol Ther. 2024 May;115(5):1092-1104. doi: 10.1002/cpt.3173. Epub 2024 Jan 16. |
| Placebo + Rituximab |
Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab. |
| Received Treatment |
|
| COMPLETED | Ongoing with treatment |
|
| NOT COMPLETED |
|
|
The number of participants was based on the Full analysis set population and a 2:1 randomization to treatment/placebo groups. Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Copanlisib + Rituximab | Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab. |
| BG001 | Placebo + Rituximab | Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern cooperative oncology group (ECOG) Performance Status (PS) | ECOG PS was measured in a scale from 0 (best) to grade 2, where 0=Fully active, able to carry on all pre-diseases performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2=Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 percent (%) waking hours (h). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) Based on Independent Central Review. | Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). | All randomized participants (FAS=full analysis set) were included. | Posted | Median | 95% Confidence Interval | Months | From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years |
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| Secondary | Objective Response Rate (ORR) | Objective response rate (ORR) was defined as the percentage of participants who have a best response rating over the whole duration of the study (i.e. until time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria (kindly refer to the links in the Protocol section). | All randomized participants (FAS) were included. | Posted | Number | Percentage of participants | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | Complete response rate (CRR) was defined as the percentage of participants who had a best response rating over the whole duration of the study (i.e., until the time of analysis of PFS) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of Complete Response according to the Owen Criteria (kindly refer to the links in the Protocol section). | All randomized participants (FAS) were included. | Posted | Number | Percentage of participants | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of response (DOR) was defined as the time (in days) from first observed tumor response Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) or Minor Response (MR) until progression or death from any cause, whichever occurred earlier according to the Owen Criteria (kindly refer to the links in the Protocol section). Only patients with response in FAS were included in the analysis. | All randomized participants (FAS) were included. | Posted | Median | 95% Confidence Interval | Months | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Disease control rate was defined as the percentage of participants who had a best response rating as Complete Response (CR), Partial Response (PR) or stable disease (SD) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) as a response rating of CR, very good partial response (VGPR), PR, minor response (MR) or stable disease (SD) according to the Owen Criteria (kindly refer to the links in the Protocol section). | All randomized participants (FAS) were included. | Posted | Number | Percentage of participants | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time to progression (TTP) was defined as the time (days) from date of randomization to date of first observed disease progression according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). | All randomized participants (FAS) were included. | Posted | Median | 95% Confidence Interval | Months | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time (in days) from randomization until death from any cause. | All randomized patients (FAS) were included. | Posted | Median | 95% Confidence Interval | Months | From randomization up to the final analysis at 15-Nov-2024 up to 9 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | Time to deterioration in DRS-P (Disease-Related Symptoms - Physical) of at least three points was defined as the time (in days) from randomization to DRS-P decline, progression, or death due to any reason, whichever occurred earlier. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. | All randomized participants (FAS) were included. | Posted | Median | 95% Confidence Interval | Months | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | Time to improvement in DRS-P (Disease-Related Symptoms - Physical) was defined as the time (in days) from randomization to DRS-P improvement of at least three points. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. | All randomized participants (FAS) were included. | Posted | Median | 95% Confidence Interval | Months | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date. | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Participants in safety analysis set (SAF) with evaluable data reported. | Posted | Number | Participants | Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date. | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Participants in safety analysis set (SAF) with evaluable data reported. | Posted | Number | Participants | Up to 30 days after end of treatment with study drug, data reporting cut-off at 7 years from the first participant randomization date |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Participants in safety analysis set (SAF) with evaluable data reported. | Posted | Number | Participants | Up to 30 days after end of treatment with study drug, data reporting cut-off at final analysis, up to 9 years |
|
|
Three patients were randomized to the placebo/rituximab arm but received at least one dose of copanlisib by mistake. These patients were included in the copanlisib/rituximab arm in the analysis of safety variables.
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 | Copanlisib + Rituximab | Copanlisib (60 mg) was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Copanlisib was administered before rituximab. | 99 | 307 | 161 | 307 | 298 | 307 |
| EG001 | Placebo + Rituximab | Placebo was administered intravenously (IV) (over approximately 1 h) on Days 1, 8, and 15 of each 28-day cycle. Rituximab (375 mg/m^2) was administered weekly during Cycle 1 on Days 1, 8, 15, and 22, and then on Day 1 of Cycles 3, 5, 7, and 9. Placebo was administered before rituximab. | 50 | 146 | 32 | 146 | 127 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Eustachian valve hypertrophy | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Administration site extravasation | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Parvovirus B19 infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Penile infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Transfusion-related acute lung injury | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Seizure like phenomena | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (27.1) | Non-systematic Assessment |
| |
| Ureteral stent removal | Surgical and medical procedures | MedDRA (27.1) | Non-systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA (27.1) | Non-systematic Assessment |
| |
| Arthrodesis | Surgical and medical procedures | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2023 | Aug 18, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589253 | copanlisib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
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 |
|
| 1 - Restricted active |
|
| 2 - Ambulatory and capable of all self-care |
|
| At data cut-off=15-Nov-2024 |
|
At 2-year follow-up cut-off date |
| Log Rank |
| 0.000003 |
1-sided p-value |
| Hazard Ratio (HR) |
| 0.557 |
| 2-Sided |
| 95 |
| 0.431 |
| 0.722 |
| Superiority |
PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model. |
| At final analysis | Log Rank | 0.000199 | 1-sided p-value | Hazard Ratio (HR) | 0.643 | 2-Sided | 95 | 0.502 | 0.823 | Superiority | PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model. |
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