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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004411-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Bortezomib and Dexamethasone | Experimental | Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 |
|
| Placebo + Bortezomib and Dexamethasone | Placebo Comparator | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Participants self-administered venetoclax tablets by mouth QD in combination with bortezomib. Venetoclax was to be given before other agents administered on the same day, if applicable. Each venetoclax dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. | Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) or Better Response Rate | The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed. | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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Inclusion Criteria:
Exclusion Criteria:
Non-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard differential, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class ≥ 3, major surgery within 4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524 | Aurora | Colorado | 80045 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40587991 | Derived | Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Onishi M, Ku G, Pothacamury R, Jalaluddin M, Zeng J, Ross JA, Dobkowska E, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma (BELLINI): final overall survival results from a randomised, phase 3 study. Lancet Haematol. 2025 Aug;12(8):e574-e587. doi: 10.1016/S2352-3026(25)00139-5. Epub 2025 Jun 27. | |
| 33129376 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Venetoclax + Bortezomib and Dexamethasone | Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 |
| 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 | Dec 16, 2020 | Jul 12, 2023 |
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|
|
| Bortezomib | Drug | Bortezomib (subcutaneous injection [preferred] or IV) was given following administration of venetoclax or placebo in Cycles 1 -8 on Days 1, 4, 8 and 11, and for Cycles 9 and beyond, on Days 1, 8, 15 and 22 and was to be administered per the prescribing information. The route of administration was to stay the same during the study. |
|
|
| Dexamethasone | Drug | Dexamethasone was to be given orally, administered per the prescribing information, the day of bortezomib dosing and the following day, given the protocol-defined dosing window (bortezomib dosing window is ± 1 day) is maintained. If bortezomib was interrupted or a dose is skipped, dexamethasone was to be administered as scheduled per protocol (unless dexamethasone was interrupted due to toxicity). |
|
| Placebo for venetoclax | Drug | Participants self-administered placebo tablets by mouth QD in combination with bortezomib. Placebo was to be given before other agents administered on the same day, if applicable. Each placebo dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling. |
|
| Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression | PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining. | Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
| Duration of Response (DOR) | DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology. | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
| Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain | The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement. | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
| Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement. | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
| Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement. | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
| Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score | PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement. | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
| Overall Survival (OS). | OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology. | Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group |
| Time to Progression (TTP) | TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology. | Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
| Overall Response Rate (ORR) | Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC). | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
| Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive. | Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR |
| Univ of Colorado Cancer Center /ID# 149130 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Duke Cancer Center /ID# 149099 | Durham | North Carolina | 27710-3000 | United States |
| Gabrail Cancer Center Research /ID# 149098 | Canton | Ohio | 44718 | United States |
| Royal Prince Alfred Hospital /ID# 149108 | Camperdown | New South Wales | 2050 | Australia |
| Concord Repatriation General Hospital /ID# 149106 | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital /ID# 149110 | Liverpool | New South Wales | 2170 | Australia |
| Royal Brisbane and Women's Hospital /ID# 149105 | Herston | Queensland | 4029 | Australia |
| The Queen Elizabeth Hospital /ID# 149104 | Woodville South | South Australia | 5011 | Australia |
| Royal Hobart Hospital /ID# 149111 | Hobart | Tasmania | 7000 | Australia |
| Box Hill Hospital /ID# 149112 | Box Hill | Victoria | 3128 | Australia |
| Peter MacCallum Cancer Ctr /ID# 149107 | Melbourne | Victoria | 3000 | Australia |
| Alfred Health /ID# 150085 | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital /ID# 148967 | Murdoch | Western Australia | 6150 | Australia |
| Perth Blood Institute Ltd /ID# 148966 | Nedlands | Western Australia | 6009 | Australia |
| Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290 | Goiânia | Goiás | 74605-020 | Brazil |
| Liga Norte Riograndense Contra o Câncer /ID# 149023 | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Hospital Sao Lucas da PUCRS /ID# 149027 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica Sao Germano /ID# 149851 | São Paulo | São Paulo | 04537-080 | Brazil |
| Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020 | Rio de Janeiro | 20231-050 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025 | São Paulo | 05403-000 | Brazil |
| Victoria Hospital /ID# 149846 | London | Ontario | N6A 4L6 | Canada |
| CISSS de la Monteregie /ID# 149844 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CHU Limoges - Dupuytren 1 /ID# 149292 | Limoges | Franche-Comte | 87042 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 149294 | Nantes | Pays de la Loire Region | 44000 | France |
| Duplicate_Centre Hospitalier Lyon Sud /ID# 149300 | Pierre-Bénite | Rhone | 69495 | France |
| CHRU de Brest - Hopital Morvan /ID# 149299 | Brest | 29200 | France |
| CHU Grenoble - Hopital Michallon /ID# 149301 | La Tronche | 38700 | France |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949 | Berlin | 10117 | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948 | Dresden | 01307 | Germany |
| Asklepios Klinik Altona /ID# 150116 | Hamburg | 22763 | Germany |
| Debreceni Egyetem Klinikai Kozpont /ID# 152517 | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516 | Kaposvár | Somogy County | 7400 | Hungary |
| Semmelweis Egyetem /ID# 152519 | Budapest | 1085 | Hungary |
| Semmelweis Egyetem /ID# 152520 | Budapest | 1085 | Hungary |
| Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518 | Budapest | 1097 | Hungary |
| University Hospital Galway /ID# 149061 | Galway | H91 YR71 | Ireland |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939 | Rome | Lazio | 00161 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942 | Ancona | 60126 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936 | Bologna | 40138 | Italy |
| Ospedale S.Eugenio /ID# 148938 | Rome | 00144 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943 | Turin | 10126 | Italy |
| Nagoya City University Hospital /ID# 150943 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Kyushu University Hospital /ID# 150896 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Ogaki Municipal Hospital /ID# 150783 | Ogaki-shi | Gifu | 503-8502 | Japan |
| Gunma University Hospital /ID# 150275 | Maebashi | Gunma | 371-8511 | Japan |
| National Hospital Organization Shibukawa Medical Center /ID# 150281 | Shibukawa-shi | Gunma | 377-0280 | Japan |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242 | Hiroshima | Hiroshima | 730-8619 | Japan |
| Kobe City Medical Center General Hospital /ID# 150944 | Kobe | Hyōgo | 650-0047 | Japan |
| National Hospital Organization Mito Medical Center /ID# 151051 | Higashi Ibaraki-gun | Ibaraki | 311-3193 | Japan |
| Duplicate_Kyoto Prefectural University of Medicine /ID# 150719 | Kyoto | Kyoto | 602-8566 | Japan |
| JCHO Kyoto Kuramaguchi Medical /ID# 150781 | Kyoto | Kyoto | 603-8151 | Japan |
| Tohoku University Hospital /ID# 150945 | Sendai | Miyagi | 9808574 | Japan |
| Okayama Medical Center /ID# 150717 | Okayama | Okayama-ken | 701-1192 | Japan |
| Japanese Red Cross Osaka Hospital /ID# 150716 | Osaka | Osaka | 543-8555 | Japan |
| Saitama Medical Center /ID# 151044 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Tochigi Cancer Center /ID# 150192 | Utsunomiya | Tochigi | 320-0834 | Japan |
| National Cancer Center Hospital /ID# 151039 | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 150780 | Koto-ku | Tokyo | 135-8550 | Japan |
| Japanese Red Cross Medical Center /ID# 149902 | Shibuya-ku | Tokyo | 150-8935 | Japan |
| National Hospital Organization Disaster Medical Center /ID# 150784 | Tachikawa-shi | Tokyo | 190-0014 | Japan |
| Kuzbass Regional Clinical Hospital /ID# 148955 | Kemerovo | Kemerovo Oblast | 650099 | Russia |
| State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956 | Ryazan | Ryazan Oblast | 390039 | Russia |
| LLC Novaya Klinika /ID# 148974 | Pyatigorsk | Stavropol Kray | 357500 | Russia |
| Central Clinical Hospital RZHD Medicine /ID# 148954 | Moscow | 129128 | Russia |
| Clinical Oncology Dispensary of Omsk /ID# 148953 | Omsk | 644013 | Russia |
| Samara State Medical University /ID# 148952 | Samara | 443099 | Russia |
| Bashkir State Medical University /ID# 151206 | Ufa | 450008 | Russia |
| National Cancer Center /ID# 150889 | Goyang | Gyeonggido | 10408 | South Korea |
| Seoul National University Bundang Hospital /ID# 150888 | Seongnam | Gyeonggido | 13620 | South Korea |
| Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Chonnam National University Hospital /ID# 150894 | Gwangju | 61469 | South Korea |
| Gachon University Gil Medical Center /ID# 150893 | Incheon | 21565 | South Korea |
| Seoul National University Hospital /ID# 150890 | Seoul | 03080 | South Korea |
| Samsung Medical Center /ID# 150892 | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895 | Seoul | 06591 | South Korea |
| Hospital Duran i Reynals /ID# 148989 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario de la Princesa /ID# 148980 | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre /ID# 148981 | Madrid | 28041 | Spain |
| Hospital Universitario Dr. Peset /ID# 148986 | Valencia | 46017 | Spain |
| Changhua Christian Hospital /ID# 154447 | Changhua City, Changhua County | 50006 | Taiwan |
| China Medical University Hospital /ID# 154446 | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital /ID# 154444 | Taipei | 100 | Taiwan |
| Taipei Veterans General Hosp /ID# 154445 | Taipei | 11217 | Taiwan |
| Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414 | Cherkasy | 18009 | Ukraine |
| Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411 | Dnipro | 49102 | Ukraine |
| National Cancer Institute /ID# 152413 | Kyiv | 03022 | Ukraine |
| Leicester Royal Infirmary /ID# 149057 | Leicester | England | LE1 5WW | United Kingdom |
| Barts Health NHS Trust /ID# 149050 | London | London, City of | E1 2ES | United Kingdom |
| Nottingham University Hospitals NHS Trust /ID# 149047 | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058 | Blackpool | FY3 8NR | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust /ID# 149059 | Canterbury | CT1 3NG | United Kingdom |
| University College London Hospitals NHS Foundation Trust /ID# 149044 | London | NW1 2PG | United Kingdom |
| King's College Hospital NHS Foundation Trust /ID# 149045 | London | SE5 9RS | United Kingdom |
| Manchester University NHS Foundation Trust /ID# 149046 | Manchester | M13 9WL | United Kingdom |
| Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055 | Romford | RM7 0AG | United Kingdom |
| The Royal Wolverhampton NHS Trust /ID# 149043 | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29. |
| FG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Venetoclax + Bortezomib and Dexamethasone | Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 |
| BG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Time since diagnosis | Median | Full Range | days |
| |||||||||||||||
| Number of prior lines of therapy | Median | Full Range | number of prior lines of therapy |
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| Number of prior lines of multiple myeloma therapy | Count of Participants | Participants | No |
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| Prior exposure to proteasome inhibitors (PI) | Count of Participants | Participants | No |
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| Prior exposure to an immunomodulatory drug (IMID) | Count of Participants | Participants | No |
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| Prior exposure to an anti-CD38 monoclonal antibody | Count of Participants | Participants | No |
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| Multiple myeloma International Staging System(ISS) stage | The International Staging System for multiple myeloma: Stage I: Serum β2 microglobulin (Sβ2M), < 3.5 mg/L; serum albumin ≥ 3.5 g/dL Stage II: Not ISS Stage I or III Stage III: Sβ2M > 5.5 mg/L Stage I represents the mildest form of multiple myeloma (best prognosis) and Stage III the most severe form (worst prognosis). | Count of Participants | Participants | No |
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| Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) | A 4 mL bone marrow aspirate sample was collected for baseline assessment of chromosomal abnormalities, including t(11;14), t(4;14), t(14;16), del 17p, 5+, 9+, 15+ | Count of Participants | Participants | No |
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| Prior stem cell transplant | 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 | Progression-free Survival (PFS) | PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Median | 95% Confidence Interval | months | Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Very Good Partial Response (VGPR) or Better Response Rate | The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression | PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization who had high BCL-2 expression | Posted | Median | 95% Confidence Interval | months | Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Duration of Response (DOR) | DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Median | 95% Confidence Interval | months | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain | The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit | Posted | Mean | Standard Deviation | units on a scale | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
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| Secondary | Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit | Posted | Mean | Standard Deviation | units on a scale | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
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| Secondary | Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit | Posted | Mean | Standard Deviation | units on a scale | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
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| Secondary | Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score | PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit | Posted | Mean | Standard Deviation | T-score | Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment |
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| Secondary | Overall Survival (OS). | OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Median | 95% Confidence Interval | months | Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group |
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| Secondary | Time to Progression (TTP) | TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Median | 95% Confidence Interval | months | Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Overall Response Rate (ORR) | Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC). | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group |
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| Secondary | Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive. | Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR |
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All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.
All-cause mortality is reported for all enrolled participants; one participant in each group did not receive 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 | Venetoclax + Bortezomib and Dexamethasone | Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 | 81 | 194 | 115 | 193 | 191 | 193 |
| EG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 | 36 | 97 | 53 | 96 | 95 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| ANGINA UNSTABLE | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| TOXIC CARDIOMYOPATHY | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INCARCERATED INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INTESTINAL PSEUDO-OBSTRUCTION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| BILIARY SEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| HEPATITIS B REACTIVATION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| LARGE INTESTINE INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| LISTERIOSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| MEDICAL DEVICE SITE INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| METAPNEUMOVIRUS INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| NECROTISING FASCIITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PARAINFLUENZAE VIRUS INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PERIODONTITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PERITONITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA ADENOVIRAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA INFLUENZAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| RHINOVIRUS INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| STREPTOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| SOFT TISSUE INJURY | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| INFLUENZA A VIRUS TEST POSITIVE | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPERVOLAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BONE LESION | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CHONDROCALCINOSIS PYROPHOSPHATE | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HAEMATOMA MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SACRAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| VERTEBRAL WEDGING | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| MALIGNANT MEDIASTINAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| NEUROENDOCRINE TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| AUTONOMIC NEUROPATHY | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SINUS DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2019 | Jul 12, 2023 | 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 |
|---|---|
| C579720 | venetoclax |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2-3 lines |
|
| Sensitive |
|
| Naïve |
|
| Unknown |
|
| MISSING |
|
| Sensitive |
|
| Naïve |
|
| Unknown |
|
| MISSING |
|
| Sensitive |
|
| Naïve |
|
| Unknown |
|
| MISSING |
|
| Stage II |
|
| Stage III |
|
| Not evaluable |
|
| MISSING |
|
| Standard |
|
| Unknown |
|
| MISSING |
|
| Allogeneic |
|
| Syngeneic |
|
| MISSING |
|
|
|
|
| Placebo + Bortezomib and Dexamethasone |
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
|
|
|
| OG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
| OG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
| OG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
| OG001 | Placebo + Bortezomib and Dexamethasone | Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
|
|
|
|
|
|
|
|
|
Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23 |
|
|
|