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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY2004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd) | Experimental | Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab. |
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| Lenalidomide+Bortezomib+Dexamethasone (RVd) | Experimental | Participants will receive lenalidomide, bortezomib and dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Cycles 1 through 6: lenalidomide 25 (milligram) mg orally on Days 1 through 14 and each cycle is of 21-days followed by maintenance treatment with lenalidomide 10 mg on days 1-21 throughout each 28-day cycle on Cycles 7 through 9. Beginning at Cycle 10, the lenalidomide dose will be increased to 15 mg unless there is a tolerability concern. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Stringent Complete Response (sCR) | Percentage of participants who had achieved sCR as determined by the validated computer algorithm according to the International Myeloma Working Group (IMWG) criteria, by the end of post-autologous stem cell transplantation (post-ASCT) consolidation treatment were reported. Complete response (CR) is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | From randomization to post-ASCT consolidation (after Cycle 6) before maintenance treatment (up to 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Better | CR or better rate is defined as the percentage of participants who achieve CR or sCR, according to the IMWG criteria. CR is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. For 2 participants (1 in each randomized treatment group), data were updated by the study sites which resulted in their inclusion to the response-evaluable analysis set after the primary analysis. |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39452950 | Derived | Voorhees PM, Sborov DW, Laubach J, Kaufman JL, Reeves B, Rodriguez C, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Bumma N, Efebera YA, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Dinner S, Gries KS, Pei H, Cortoos A, Patel S, Lin TS, Usmani SZ, Richardson PG. A plain language summary of the final analysis of the GRIFFIN study of daratumumab plus lenalidomide, bortezomib, and dexamethasone for people with newly diagnosed multiple myeloma. Future Oncol. 2025 Jan;21(1):25-49. doi: 10.1080/14796694.2024.2408909. Epub 2024 Oct 25. | |
| 39287147 |
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Participant was a screen-failure but was mistakenly randomized first to D-RVd ; after re-screening was randomized to RVd group. The participant was counted in D-RVd for ITT analysis and RVd for safety analysis. So, safety analysis set included 99 participants in D-RVd and 102 in RVd group who received at least 1 dose of study treatment.
223 participants were enrolled/randomized (16 in safety run-in,104 to D-RVd and 103 to RVd group). Among 207 (D-RVd [104]+RVd [103]) randomized, 201 received treatment (D-RVd: 100 and RVd: 101). 1 participant randomized to D-RVd group received RVd treatment and was randomized twice (resulting a total of 224 participants).
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
| 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 | Jan 10, 2019 | Jan 24, 2020 |
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| Bortezomib | Drug | Bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 4, 8, and 11 during Cycles 1-6. |
|
| Dexamethasone | Drug | Dexamethasone 40 mg orally every week (20 mg on Days 1, 2, 8, 9, 15, and 16). |
|
| Daratumumab | Drug | Daratumumab intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly during induction treatment (Days 1, 8, and 15 of Cycles 1 through 4), and every 3 weeks during consolidation treatment (Day 1 of Cycles 5 and 6), followed by maintenance treatment with daratumumab every 4 or 8 weeks. |
|
| From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months) |
| Percentage of Participants With Overall Stringent Complete Response (sCR) | Overall sCR rate is defined as the percentage of participants who achieved sCR, according to the IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5 % PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months) |
| Percentage of Participants With Overall Response Rate (ORR) | ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response [VGPR], CR or sCR) based on computerized algorithm as per IMWG criteria. PR -greater than or equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months) |
| Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better | VGPR or better rate is defined as the percentage of participants who achieved VGPR or better, according to the IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months) |
| Percentage of Participants With Negative Minimal Residual Disease (MRD) | Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. Minimal residual disease was evaluated in participants who achieved CR or sCR (including participants with VGPR or better and suspected daratumumab interference) using next-generation sequencing which utilizes multiple myeloma cell DNA from bone marrow aspirates at a threshold of less than (<) 10^5. | From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months), and at the end of maintenance period of 24 months (overall duration up to 34 months) |
| Duration of Complete Response or Better | Duration of CR or better is the duration from the date of initial documentation of a CR or sCR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease (PR), or relapse from CR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligrams [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to plasma cells (PCs) proliferative disorder. | From randomization to the date of first documented evidence of progressive disease or relapse from CR (up to 5 years) |
| Duration of Stringent Complete Response (sCR) | Duration of sCR is the duration from the date of initial documentation of a sCR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease, or relapse from sCR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | From randomization to the date of first documented evidence of progressive disease or relapse from sCR (up to 5 years) |
| Time to Stringent Complete Response (sCR) | Time to sCR is the duration from the date of randomization to the date of initial documentation of sCR, which was confirmed by a repeated measurement as required by the IMWG criteria. | From randomization to the date of initial documentation of sCR (up to 5 years) |
| Time to Complete Response or Better | Time to CR or better is the duration from the date of randomization to the date of initial documentation of CR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | From randomization to the date of initial documentation of CR (up to 5 years) |
| Time to Very Good Partial Response (VGPR) or Better | Time to VGPR or better is the duration from the date of randomization to the date of initial documentation of VGPR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | From randomization to the date of initial documentation of VGPR or better (up to 5 years) |
| Time to Partial Response (PR) or Better | Time to PR or better is the duration from the date of randomization to the date of initial documentation of PR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | From randomization to the date of initial documentation of PR or better (up to 5 years) |
| Progression-free Survival (PFS) | PFS is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease or death, whichever comes first. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | From randomization to the date of first documented evidence of progressive disease or death (up to 5 years) |
| Overall Survival (OS) | OS is measured from the date of randomization to the date of the participant's death. | From randomization to the date of initial documentation of participant's death (up to 5 years) |
| Time to Progression (TTP) | TTP is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease according to the IMWG criteria. | From randomization to the date of first documented evidence of progressive disease (up to 5 years) |
| Duration of Response | Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | From the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive (up to 5 years) |
| Duarte |
| California |
| United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Westwood | Kansas | United States |
| New Orleans | Louisiana | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Detroit | Michigan | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Columbus | Ohio | United States |
| Portland | Oregon | United States |
| Abington | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Derived |
| Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, Hulin C, Antonioli E, Leleu X, Mangiacavalli S, Perrot A, Cavo M, Belotti A, Broijl A, Gay F, Mina R, van de Donk NWCJ, Katodritou E, Schjesvold F, Balari AS, Rosinol L, Delforge M, Roeloffzen W, Silzle T, Vangsted A, Einsele H, Spencer A, Hajek R, Jurczyszyn A, Lonergan S, Ahmadi T, Liu Y, Wang J, Vieyra D, van Brummelen EMJ, Vanquickelberghe V, Sitthi-Amorn A, de Boer CJ, Carson R, Rodriguez-Otero P, Blade J, Moreau P. A plain language summary of the PERSEUS study of daratumumab plus bortezomib, lenalidomide, and dexamethasone for treating newly diagnosed multiple myeloma. Future Oncol. 2024;20(38):3043-3063. doi: 10.1080/14796694.2024.2394323. Epub 2024 Sep 17. |
| 38977707 | Derived | Chari A, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Bumma N, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Pei H, Cortoos A, Patel S, Lin TS, Voorhees PM, Usmani SZ, Richardson PG. Daratumumab in transplant-eligible patients with newly diagnosed multiple myeloma: final analysis of clinically relevant subgroups in GRIFFIN. Blood Cancer J. 2024 Jul 8;14(1):107. doi: 10.1038/s41408-024-01088-6. |
| 38649340 | Derived | Callander NS, Silbermann R, Kaufman JL, Godby KN, Laubach J, Schmidt TM, Sborov DW, Medvedova E, Reeves B, Dhakal B, Rodriguez C, Chhabra S, Chari A, Bal S, Anderson LD Jr, Dholaria BR, Nathwani N, Hari P, Shah N, Bumma N, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Pei H, Cortoos A, Patel S, Lin TS, Giri S, Costa LJ, Usmani SZ, Richardson PG, Voorhees PM. Daratumumab-based quadruplet therapy for transplant-eligible newly diagnosed multiple myeloma with high cytogenetic risk. Blood Cancer J. 2024 Apr 22;14(1):69. doi: 10.1038/s41408-024-01030-w. |
| 38622840 | Derived | Silbermann R, Laubach J, Kaufman JL, Sborov DW, Reeves B, Rodriguez C, Chari A, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Bumma N, Holstein SA, Costello C, Jakubowiak A, Orlowski RZ, Shain KH, Cowan AJ, Gries KS, Pei H, Cortoos A, Patel S, Lin TS, Voorhees PM, Usmani SZ, Richardson PG. Health-related quality of life in transplant-eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: Patient-reported outcomes from GRIFFIN. Am J Hematol. 2024 Jul;99(7):1257-1268. doi: 10.1002/ajh.27326. Epub 2024 Apr 15. |
| 37708911 | Derived | Voorhees PM, Sborov DW, Laubach J, Kaufman JL, Reeves B, Rodriguez C, Chari A, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Bumma N, Efebera YA, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Dinner S, Pei H, Cortoos A, Patel S, Lin TS, Usmani SZ, Richardson PG. Addition of daratumumab to lenalidomide, bortezomib, and dexamethasone for transplantation-eligible patients with newly diagnosed multiple myeloma (GRIFFIN): final analysis of an open-label, randomised, phase 2 trial. Lancet Haematol. 2023 Oct;10(10):e825-e837. doi: 10.1016/S2352-3026(23)00217-X. Epub 2023 Sep 11. |
| 36799429 | Derived | Nooka AK, Kaufman JL, Rodriguez C, Jakubowiak A, Efebera Y, Reeves B, Wildes T, Holstein SA, Anderson LD Jr, Badros A, Shune L, Chari A, Pei H, Cortoos A, Patel S, Lin TS, Richardson PG, Voorhees P. A plain language summary of daratumumab plus lenalidomide/bortezomib/dexamethasone in transplant-eligible Black patients with newly diagnosed multiple myeloma in the GRIFFIN study. Future Oncol. 2022 Dec;18(40):4443-4456. doi: 10.2217/fon-2022-0775. Epub 2023 Feb 17. |
| 36111391 | Derived | Sborov DW, Baljevic M, Reeves B, Laubach J, Efebera YA, Rodriguez C, Costa LJ, Chari A, Silbermann R, Holstein SA, Anderson LD Jr, Kaufman JL, Shah N, Pei H, Patel S, Cortoos A, Bartlett JB, Vermeulen J, Lin TS, Voorhees PM, Richardson PG. Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the GRIFFIN study. Br J Haematol. 2022 Nov;199(3):355-365. doi: 10.1111/bjh.18432. Epub 2022 Sep 16. |
| 35985959 | Derived | Swan D, Henderson R, McEllistrim C, Naicker SD, Quinn J, Cahill MR, Mykytiv V, Lenihan E, Mulvaney E, Nolan M, Parker I, Natoni A, Lynch K, Ryan AE, Szegezdi E, Krawczyk J, Murphy P, O'Dwyer M. CyBorD-DARA in Newly Diagnosed Transplant-Eligible Multiple Myeloma: Results from the 16-BCNI-001/CTRIAL-IE 16-02 Study Show High Rates of MRD Negativity at End of Treatment. Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):847-852. doi: 10.1016/j.clml.2022.07.011. Epub 2022 Jul 21. |
| 33606004 | Derived | Voorhees PM, Rodriguez C, Reeves B, Nathwani N, Costa LJ, Lutska Y, Bobba P, Hoehn D, Pei H, Ukropec J, Qi M, Lin TS, Richardson PG. Daratumumab plus RVd for newly diagnosed multiple myeloma: final analysis of the safety run-in cohort of GRIFFIN. Blood Adv. 2021 Feb 23;5(4):1092-1096. doi: 10.1182/bloodadvances.2020003642. |
| 32325490 | Derived | Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, Chari A, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Efebera YA, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Murphy S, Lutska Y, Pei H, Ukropec J, Vermeulen J, de Boer C, Hoehn D, Lin TS, Richardson PG. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020 Aug 20;136(8):936-945. doi: 10.1182/blood.2020005288. |
| FG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| FG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
| Treated (Safety Analysis Set) |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
| BG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| BG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Race/Ethnicity, Customized | 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 | Percentage of Participants With Stringent Complete Response (sCR) | Percentage of participants who had achieved sCR as determined by the validated computer algorithm according to the International Myeloma Working Group (IMWG) criteria, by the end of post-autologous stem cell transplantation (post-ASCT) consolidation treatment were reported. Complete response (CR) is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. The outcome measure was planned to be reported for randomized participants only. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to post-ASCT consolidation (after Cycle 6) before maintenance treatment (up to 10 months) |
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| Secondary | Percentage of Participants With Complete Response (CR) or Better | CR or better rate is defined as the percentage of participants who achieve CR or sCR, according to the IMWG criteria. CR is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. For 2 participants (1 in each randomized treatment group), data were updated by the study sites which resulted in their inclusion to the response-evaluable analysis set after the primary analysis. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months) |
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| Secondary | Percentage of Participants With Overall Stringent Complete Response (sCR) | Overall sCR rate is defined as the percentage of participants who achieved sCR, according to the IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5 % PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months) |
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| Secondary | Percentage of Participants With Overall Response Rate (ORR) | ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response [VGPR], CR or sCR) based on computerized algorithm as per IMWG criteria. PR -greater than or equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance treatment of 24 months (overall duration up to 34 months) |
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| Secondary | Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better | VGPR or better rate is defined as the percentage of participants who achieved VGPR or better, according to the IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. | Population analyzed included response evaluable analysis set who achieved response (PR or better). Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and at the end of maintenance period of 24 months (overall duration up to 34 months) |
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| Secondary | Percentage of Participants With Negative Minimal Residual Disease (MRD) | Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. Minimal residual disease was evaluated in participants who achieved CR or sCR (including participants with VGPR or better and suspected daratumumab interference) using next-generation sequencing which utilizes multiple myeloma cell DNA from bone marrow aspirates at a threshold of less than (<) 10^5. | Intent to treat (ITT) analysis set which included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months), and at the end of maintenance period of 24 months (overall duration up to 34 months) |
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| Secondary | Duration of Complete Response or Better | Duration of CR or better is the duration from the date of initial documentation of a CR or sCR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease (PR), or relapse from CR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligrams [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to plasma cells (PCs) proliferative disorder. | Population analyzed included response evaluable analysis set who achieved response (PR or better). | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented evidence of progressive disease or relapse from CR (up to 5 years) |
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| Secondary | Duration of Stringent Complete Response (sCR) | Duration of sCR is the duration from the date of initial documentation of a sCR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease, or relapse from sCR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | Population analyzed included response evaluable analysis set who achieved response PR or better. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented evidence of progressive disease or relapse from sCR (up to 5 years) |
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| Secondary | Time to Stringent Complete Response (sCR) | Time to sCR is the duration from the date of randomization to the date of initial documentation of sCR, which was confirmed by a repeated measurement as required by the IMWG criteria. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of initial documentation of sCR (up to 5 years) |
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| Secondary | Time to Complete Response or Better | Time to CR or better is the duration from the date of randomization to the date of initial documentation of CR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of initial documentation of CR (up to 5 years) |
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| Secondary | Time to Very Good Partial Response (VGPR) or Better | Time to VGPR or better is the duration from the date of randomization to the date of initial documentation of VGPR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of initial documentation of VGPR or better (up to 5 years) |
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| Secondary | Time to Partial Response (PR) or Better | Time to PR or better is the duration from the date of randomization to the date of initial documentation of PR or better, which was confirmed by a repeated measurement as required by the IMWG criteria. | Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of initial documentation of PR or better (up to 5 years) |
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| Secondary | Progression-free Survival (PFS) | PFS is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease or death, whichever comes first. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | ITT analysis set which included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented evidence of progressive disease or death (up to 5 years) |
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| Secondary | Overall Survival (OS) | OS is measured from the date of randomization to the date of the participant's death. | ITT analysis set which included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of initial documentation of participant's death (up to 5 years) |
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| Secondary | Time to Progression (TTP) | TTP is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease according to the IMWG criteria. | ITT analysis set which included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented evidence of progressive disease (up to 5 years) |
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| Secondary | Duration of Response | Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | Population analyzed included response evaluable analysis set who achieved response PR or better. | Posted | Median | 95% Confidence Interval | Months | From the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive (up to 5 years) |
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Other adverse events and serious adverse events: up to 30 days after the last dose of study treatment (up to 3 years); All-cause mortality: up to end of study (up to 5 years)
4 participants in D-RVd and 2 in RVd group were randomized but did not receive any treatment. 1 participant in D-RVd group received RVd and was counted in D-RVd group for ITT and RVd group for safety analysis. So, safety analysis set (SAS) included 99 participants in D-RVd and 102 in RVd group. All-cause mortality was assessed in ITT set (included all randomized participants). SAEs and other AEs were assessed on SAS which included all participants who received at least 1 dose of study drugs.
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 | Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. | 7 | 103 | 53 | 102 | 102 | 102 |
| EG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. | 7 | 104 | 46 | 99 | 99 | 99 |
| EG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. | 1 | 16 | 12 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Atrial Tachycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sickle Cell Anaemia | Congenital, familial and genetic disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Intestinal Infarction | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Systemic Inflammatory Response Syndrome | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Serum Sickness-Like Reaction | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Acute Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Adenovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Aspergillus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Corona Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Escherichia Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastroenteritis Escherichia Coli | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| H1n1 Influenza | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Herpes Zoster Disseminated | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Parainfluenzae Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Periorbital Abscess | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumococcal Bacteraemia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonia Bacterial | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonia Legionella | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Respiratory Syncytial Virus Bronchiolitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rhinovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Septic Shock | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Clostridium Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Human Rhinovirus Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Bladder Perforation | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Glomerulonephritis Membranoproliferative | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Drug Reaction with Eosinophilia and Systemic Symptoms | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypersensitivity Vasculitis | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Congestion | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Discomfort | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Eye Swelling | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Dysaesthesia | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Injection Site Rash | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Localised Oedema | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Swelling Face | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Anal Tinea | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis Bacterial | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Metapneumovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pneumonia Influenzal | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash Pustular | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Post-Traumatic Pain | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vascular Access Site Swelling | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Adjusted Calcium | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Coronavirus Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haematocrit Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Human Rhinovirus Test Positive | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Protein Total Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Osteonecrosis of Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Trigger Finger | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cerebral Congestion | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Disturbance in Attention | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinus Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Taste Disorder | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Libido Decreased | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vaginal Fistula | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Vulvovaginal Pruritus | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Laryngeal Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sinus Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Ingrowing Nail | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Skin Mass | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Orthostatic Hypertension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
|
Initial protocol did not require minimal residual disease (MRD) testing in all participants, impacting the interpretation of MRD negativity rates in intent-to-treat (ITT) group, which strongly favored daratumumab treatment. Sensitivity analysis, including MRD negativity rate in participants with a complete response (CR) or better and with an informative baseline clone and follow-up MRD testing, were performed and confirmed a strong benefit for daratumumab treatment.
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 | |
|---|---|---|---|---|
| Clinical Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2019 | Jan 24, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy [HDT] and autologous stem cell transplantation [ASCT]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week [until disease progression/up to maximum of 2 years])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
|
|
| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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| Randomized: Daratumumab+RVd (D-RVd) |
Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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| OG001 | Randomized: Daratumumab+RVd (D-RVd) | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator. |
| OG002 | Safety Run-in: D-RVd | Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week [until disease progression/up to maximum of 2 years])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. |
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