Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002261-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
After completing the treatment period, all participants will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, participants who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968 (NCT05041309).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axicabtagene Ciloleucel Treatment | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. Participants who will achieve a partial response or complete response and subsequently experience disease progression may have an option to receive a second course of conditioning chemotherapy and axicabtagene ciloleucel. |
|
| Standard of Care Therapy | Active Comparator | Participants will receive 2 or 3, 21-day cycles of second-line chemotherapy:
Responders will receive high-dose therapy and autologous stem cell transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) Per Blinded Central Assessment | EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately > liver) or 5 (uptake markedly > liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter > 1.5 cm, ≥ 50% increase from nadir; Splenic length increase > 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis. | From randomization date up to a median follow-up: 24.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Blinded Central Assessment | ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake >mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately >liver), 5 (uptake markedly >liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased >50% if previously enlarged, no new lesion sites. |
Not provided
Key Inclusion Criteria:
Histologically proven large B-cell lymphoma (BCL) including the following types defined by World Health Organization (WHO) 2016.
Relapsed or refractory disease after first-line chemoimmunotherapy.
Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.
Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy.
Individuals must have received adequate first-line therapy including at a minimum:
No known history or suspicion of central nervous system involvement by lymphoma.
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Adequate bone marrow function as evidenced by:
Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25113753 | Background | Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800. | |
| 26980727 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
437 participants were screened.
Participants were enrolled at study sites in North America, Middle East, Europe, and Australia.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Axicabtagene Ciloleucel | Participants received cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion and fludarabine 30 mg/m^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2023 | Sep 26, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Platinum-containing Salvage Chemotherapy | Drug | Platinum-containing salvage chemotherapy (Rituximab-ifosfamide, carboplatin, etoposide (R-ICE), Rituximab-dexamethasone, cytarabine, cisplatin,oxaliplatin (R-DHAP), Rituximab-etoposide, methylprednisolone, cisplatin, cytarabine (R-ESHAP), or Rituximab-gemcitabine, dexamethasone, cisplatin/carboplatin (R-GDP) as selected by treating investigator). |
|
| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
| From randomization date up to a median follow-up: 24.9 months |
| Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis. | Up to 74.9 months |
| Duration of Response (DOR) Per Blinded Central Assessments | DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis. | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months) |
| Modified Event Free Survival (mEFS) Per Blinded Central Assessment | Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | From randomization date up to a median follow-up: 24.9 months |
| EFS Per Investigator Disease Assessments | EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1. | From randomization date up to a median follow-up: 47.2 months |
| Progression-Free Survival (PFS) Per Investigator Disease Assessments | PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis. | From randomization date up to a median follow-up: 47.2 months |
| Modified Event Free Survival (mEFS) Per Investigator Assessment | mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | From randomization date up to a median follow-up: 47.2 months |
| Change From Baseline in Global Health Status Scores | Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL. | Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in EORTC QLQ-C30 Physical Functioning Score | The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL. | Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24 |
| Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score | The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement. | Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in EQ-5D-5L VAS Scale Score | The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement. | Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24 |
| Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies | Up to 74.9 months |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy. | From first dose up to 61.8 months |
| Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off. | From first dose up to 61.8 months |
| Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off. | From first dose up to 61.8 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| UCLA | Santa Monica | California | 90404 | United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Moffitt Cancer Center | Tampa | Florida | 12902 | United States |
| Northwestern University | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals and Clinincs | Iowa City | Iowa | 52242 | United States |
| The University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Maryland, Greenbaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mayo Clinic, Patient Location | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63130 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Henry-Joyce Cancer Center | Nashville | Tennessee | 37232 | United States |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia |
| Universitatsklinikum Graz, Division of Hematology | Graz | 6020 | Austria |
| Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie | Innsbruck | 6020 | Austria |
| Cliniques Universiaires Saint-Luc | Brussels | Belgium |
| UZ Gasthuisberg | Leuven | Belgium |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Uninversity Health Network - Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Center | Montreal | Quebec | H4A 3J1 | Canada |
| QEII Health Sciences Centre | Halifax | B3H 2Y9 | Canada |
| Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont | Montreal | H1T 2M4 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | K1H 8L6 | Canada |
| CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus | Québec | G1J 1Z4 | Canada |
| CHRU de Lille - Hopital Claude Huriez | Lille | 59037 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | 35033 | France |
| Universitäts-klinikum Dresden | Dresden | 01307 | Germany |
| Universitatsmedizin Gottingen | Göttingen | 37075 | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitäts-klinikum Würzburg | Würzburg | 97080 | Germany |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale | Bologna | 40138 | Italy |
| IRCCS Ospedale San Raffaele di Milano | Milan | 20132 | Italy |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Erasmus Medical Center | Rotterdam | 3011PL | Netherlands |
| University Medical Center Utrecht | Utrecht | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Institut Catala d'Oncologia | Barcelona | 08908 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Uppsala Akademiska Sjukhus | Uppsala | 75185 | Sweden |
| IOSI, OSpedale Regionale Bellinzona e Valli | Bellinzona | 6500 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2GW | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| Background |
| Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15. |
| 35839452 | Background | Elsawy M, Chavez JC, Avivi I, Larouche JF, Wannesson L, Cwynarski K, Osman K, Davison K, Rudzki JD, Dahiya S, Dorritie K, Jaglowski S, Radford J, Morschhauser F, Cunningham D, Martin Garcia-Sancho A, Tzachanis D, Ulrickson ML, Karmali R, Kekre N, Thieblemont C, Enblad G, Dreger P, Malladi R, Joshi N, Wang WJ, Solem CT, Snider JT, Cheng P, To C, Kersten MJ. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022 Nov 24;140(21):2248-2260. doi: 10.1182/blood.2022015478. |
| 36646322 | Background | Kersten MJ, Qiao Y, Shah R, Solem C, Snider JT, To C, Cheng P, Spooner C, Perales MA. Quality-Adjusted Time without Symptoms or Toxicity: Analysis of Axicabtagene Ciloleucel versus Standard of Care in Patients with Relapsed/Refractory Large B Cell Lymphoma. Transplant Cell Ther. 2023 May;29(5):335.e1-335.e8. doi: 10.1016/j.jtct.2023.01.008. Epub 2023 Jan 14. |
| 34891224 | Background | Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Munoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11. |
| 36999993 | Background | Westin JR, Locke FL, Dickinson M, Ghobadi A, Elsawy M, van Meerten T, Miklos DB, Ulrickson ML, Perales MA, Farooq U, Wannesson L, Leslie L, Kersten MJ, Jacobson CA, Pagel JM, Wulf G, Johnston P, Rapoport AP, Du L, Vardhanabhuti S, Filosto S, Shah J, Snider JT, Cheng P, To C, Oluwole OO, Sureda A. Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma. Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 10.1158/1078-0432.CCR-22-3136. |
| 37272527 | Background | Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales MA, Ghobadi A, Rapoport AP, Sureda A, Jacobson CA, Farooq U, van Meerten T, Ulrickson M, Elsawy M, Leslie LA, Chaganti S, Dickinson M, Dorritie K, Reagan PM, McGuirk J, Song KW, Riedell PA, Minnema MC, Yang Y, Vardhanabhuti S, Filosto S, Cheng P, Shahani SA, Schupp M, To C, Locke FL; ZUMA-7 Investigators; Kite Members. Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma. N Engl J Med. 2023 Jul 13;389(2):148-157. doi: 10.1056/NEJMoa2301665. Epub 2023 Jun 5. |
| Background | Filosto S, Vardhanabhuti S, Canales M, Poiré X, Lekakis LJ, de Vos S, et al. Product attributes of axicabtagene ciloleucel (axi-cel) that associate differentially with efficacy and toxicity in second-line large B-cell lymphoma. Cancer Res. 2022;82(12_Supplement):CT004. |
| Background | Ghobadi A, Munoz J, Westin J, Locke FL, Miklos DB, Rapoport AP, et al. Outcomes of Subsequent Anti-Lymphoma Therapies in Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7 Study. Blood. 2022;140(Supplement 1):1595-1597. |
| Background | Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, et al. Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7. Blood. 2022;140(Supplement 1):638-640. |
| 39240498 | Background | Chartier M, Filosto S, Peyret T, Chiney M, Milletti F, Budka J, Ndi A, Dong J, Vardhanabhuti S, Mao D, Duffull S, Dodds M, Shen R. Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin's Lymphoma. Clin Pharmacokinet. 2024 Sep;63(9):1283-1299. doi: 10.1007/s40262-024-01413-z. Epub 2024 Sep 6. |
| 37983485 | Background | Filosto S, Vardhanabhuti S, Canales MA, Poire X, Lekakis LJ, de Vos S, Portell CA, Wang Z, To C, Schupp M, Poddar S, Trinh T, Warren CM, Aguilar EG, Budka J, Cheng P, Chou J, Bot A, Shen RR, Westin JR. Product Attributes of CAR T-cell Therapy Differentially Associate with Efficacy and Toxicity in Second-line Large B-cell Lymphoma (ZUMA-7). Blood Cancer Discov. 2024 Jan 8;5(1):21-33. doi: 10.1158/2643-3230.BCD-23-0112. |
| 38315832 | Background | Ghobadi A, Munoz J, Westin JR, Locke FL, Miklos DB, Rapoport AP, Perales MA, Reagan PM, McGuirk J, Jacobson CA, Kersten MJ, Avivi I, Peng A, Schupp M, To C, Oluwole OO. Outcomes of subsequent antilymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7. Blood Adv. 2024 Jun 11;8(11):2982-2990. doi: 10.1182/bloodadvances.2023011532. |
| Background | Locke FL, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, et al. Association of pretreatment (preTx) tumor characteristics and clinical outcomes following second-line (2L) axicabtagene ciloleucel (axi-cel) versus standard of care (SOC) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). J Clin Oncol.2022;40(16_suppl):7565 |
| 38233586 | Background | Locke FL, Filosto S, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, Lee C, Zinzani PL, Kroger N, Lopez-Guillermo A, Greinix H, Zhang W, Tiwari G, Budka J, Marincola FM, To C, Mattie M, Schupp M, Cheng P, Bot A, Shen R, Bedognetti D, Miao H, Galon J. Impact of tumor microenvironment on efficacy of anti-CD19 CAR T cell therapy or chemotherapy and transplant in large B cell lymphoma. Nat Med. 2024 Feb;30(2):507-518. doi: 10.1038/s41591-023-02754-1. Epub 2024 Jan 17. |
| 38557775 | Background | Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, Rowe SP, Vardhanabhuti S, Winters J, Filosto S, To C, Cheng P, Schupp M, Korn R, Kersten MJ. Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume. Blood. 2024 Jun 13;143(24):2464-2473. doi: 10.1182/blood.2023021620. |
| 38504387 | Background | Lunning MA, Wang HL, Hu ZH, Locke FL, Siddiqi T, Jacobson CA, Ahmed S, Miklos DB, Lin Y, Hill BT, Ghobadi A, Neelapu SS, Westin J, Dieyi C, Field P, Miao H, Shahani SA, Patel A, Spooner C, Fu C, Muramoto D, Xu H, Pasquini MC. Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B-cell lymphoma after 2 or more lines of prior therapy. Am J Hematol. 2024 May;99(5):880-889. doi: 10.1002/ajh.27283. Epub 2024 Mar 19. |
| 40083872 | Background | Tian Y, Budka J, Locke FL, Westin JR, To C, Tiwari G, Mao D, Bedognetti D, Shen RR, Andrade J, Filosto S. Tumor gene expression signatures associated with outcome in large B-cell lymphoma treated with CD19-directed CAR T-cell therapy (axicabtagene ciloleucel). Front Oncol. 2025 Feb 27;15:1519473. doi: 10.3389/fonc.2025.1519473. eCollection 2025. |
| 38635762 | Derived | Locke FL, Siddiqi T, Jacobson CA, Ghobadi A, Ahmed S, Miklos DB, Perales MA, Munoz J, Fingrut WB, Pennisi M, Gauthier J, Shadman M, Gowda L, Mirza AS, Abid MB, Hong S, Majhail NS, Kharfan-Dabaja MA, Khurana A, Badar T, Lin Y, Bennani NN, Herr MM, Hu ZH, Wang HL, Baer A, Baro E, Miao H, Spooner C, Xu H, Pasquini MC. Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity. Blood. 2024 Jun 27;143(26):2722-2734. doi: 10.1182/blood.2023023447. |
| 35114155 | Derived | The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4. No abstract available. |
| 34922648 | Derived | Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available. |
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
| 33288485 | Derived | Thiruvengadam SK, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11. |
| FG001 | Standard of Care Therapy | Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: R-ICE: rituximab 375mg/m^2 before chemotherapy, ifosfamide 5g/m^2 24 hours continuous infusion (CI) on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m^2/day on Days 1-3; R-ESHAP: rituximab 375mg/m^2 Day 1, etoposide 40mg/m^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m^2/day CI Days 1-4, cytarabine 2g/m^2 on Day 5; R-GDP: rituximab 375mg/m^2 Day 1 (or Day 8), gemcitabine 1g/m^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m^2 Day 1 or carboplatin AUC=5; or R-DHAP: rituximab 375mg/m^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m^2 24 hours CI on Day 1 or oxaliplatin 100mg/m^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axicabtagene Ciloleucel | Participants received cyclophosphamide 500 mg/m^2/day IV infusion and fludarabine 30 mg/m^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0. |
| BG001 | Standard of Care Therapy | Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Free Survival (EFS) Per Blinded Central Assessment | EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately > liver) or 5 (uptake markedly > liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter > 1.5 cm, ≥ 50% increase from nadir; Splenic length increase > 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis. | Participants in Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization date up to a median follow-up: 24.9 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Blinded Central Assessment | ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake >mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately >liver), 5 (uptake markedly >liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased >50% if previously enlarged, no new lesion sites. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization date up to a median follow-up: 24.9 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 74.9 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per Blinded Central Assessments | DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis. | Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier. | Posted | Median | 95% Confidence Interval | months | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Event Free Survival (mEFS) Per Blinded Central Assessment | Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization date up to a median follow-up: 24.9 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EFS Per Investigator Disease Assessments | EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization date up to a median follow-up: 47.2 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Per Investigator Disease Assessments | PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization date up to a median follow-up: 47.2 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Event Free Survival (mEFS) Per Investigator Assessment | mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization date up to a median follow-up: 47.2 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Health Status Scores | Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL. | Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment. | Posted | Mean | Standard Deviation | Score on scale | Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning Score | The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL. | Participants in QoL analysis set with data available at given timepoint were analyzed. | Posted | Mean | Standard Deviation | Score on scale | Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score | The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement. | Participants in QoL analysis set with data available at given timepoint were analyzed. | Posted | Mean | Standard Deviation | Score on scale | Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-5D-5L VAS Scale Score | The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement. | Participants in QoL analysis set with data available at given timepoint were analyzed. | Posted | Mean | Standard Deviation | Score on scale | Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies | Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set was defined as the subset of all randomized participants who received at least 1 dose of axicabtagene ciloleucel as protocol therapy or SOC chemotherapy as protocol therapy. | Posted | Count of Participants | Participants | No | Up to 74.9 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | From first dose up to 61.8 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | From first dose up to 61.8 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | From first dose up to 61.8 months |
|
All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants.
Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel.
Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
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 | Axicabtagene Ciloleucel Treatment | Participants received cyclophosphamide 500 mg/m^2/day IV infusion and fludarabine 30 mg/m^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. | 81 | 180 | 96 | 170 | 170 | 170 |
| EG001 | Standard of Care Therapy | Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant. | 101 | 179 | 78 | 168 | 166 | 168 |
| EG002 | Retreatment Axicabtagene Ciloleucel | Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m^2/day IV infusion and fludarabine 30 mg/m^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-CD 19 CAR transduced autologous T cells/kg. | 3 | 10 | 2 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Heart failure with reduced ejection fraction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fungal cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood stem cell harvest failure | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Large granular lymphocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Spindle cell sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Faecaluria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematopoietic stem cell mobilisation | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2020 | Nov 21, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| Switzerland |
|
| Spain |
|
| Canada |
|
| Belgium |
|
| Netherlands |
|
| Sweden |
|
| Italy |
|
| Israel |
|
| Australia |
|
| France |
|
| Germany |
|
| Austria |
|
| Standard of Care Therapy |
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|