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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003667-11 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.
Following the Screening period, all eligible participants initiate venetoclax on a once daily (QD) dosing schedule. To mitigate the risk for tumor lysis syndrome (TLS), dosing will start with a 5-week dose titration phase.
Participants may receive venetoclax for up to 2 years provided they continue to tolerate the drug, have no evidence of disease progression (based on investigator assessment), do not have unacceptable toxicity and do not meet any of the criteria for subject discontinuation. In countries where venetoclax is not commercially available, participants who continued to derive benefit after 2 years of treatment may extend their treatment for up to 2 additional years in an extended access phase. Participants in the extended access phase of this study who continue to derive benefit from venetoclax after the 2-year extension and are transferring to the venetoclax extension study, Study M19-388 (NCT03844048), may remain in Extended Access for up to 1 additional year or until the extension study is approved and initiated at the site, whichever is sooner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax | Experimental | Venetoclax will be administered orally once daily (QD) beginning with a dose-titration phase. The initial venetoclax dose is 20 mg QD. After 1 week of treatment at 20 mg QD, the dose will be escalated to 50 mg QD followed by subsequent increases, each after 1 week, to 100 mg QD, 200 mg QD and the maximum dose of 400 mg QD. Participants may continue to receive venetoclax for up to 2 years provided they continue to tolerate the drug, have no evidence of disease progression (based on investigator's assessment), do not have unacceptable toxicity, and do not meet any of the criteria for discontinuation. In countries where venetoclax is not commercially available, participants who continue to derive benefit after 2 years of treatment may be able to extend their treatment for up to 2 additional years, plus one additional year until the venetoclax extension study was open, determined on a case by case basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Tablets for oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Final Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. |
Inclusion Criteria:
Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
Participant has relapsed/refractory disease (received at least 1 prior therapy)
Participant has diagnosis of CLL that meets published 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines and:
In addition, participants:
Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory at Screening
Exclusion Criteria:
Participant has developed Richter's transformation or Prolymphocytic leukemia
Participant has previously received venetoclax
History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
Participant has undergone an allogeneic stem cell transplant
Treatment with any of the following within five half-lives or 14 days (if half-life unknown) as applicable prior to the first dose of venetoclax, or clinically significant adverse effect(s)/toxicity(s) of the previous therapy have not resolved to < National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade 2:
Participant is human immunodeficiency virus (HIV) positive
Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Cancer Institute /ID# 149788 | Louisville | Kentucky | 40202-3700 | United States | ||
| St. Agnes Cancer Center /ID# 149782 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467131 | Derived | Kater AP, Arslan O, Demirkan F, Herishanu Y, Ferhanoglu B, Diaz MG, Leber B, Montillo M, Panayiotidis P, Rossi D, Skarbnik A, Tempescul A, Turgut M, Mellink CH, van der Kevie-Kersemaekers AF, Lanham S, Sale B, Del Rio L, Popovic R, Chyla BJ, Busman T, Komlosi V, Wang X, Sail K, Pena GE, Vizkelety T, Forconi F. Activity of venetoclax in patients with relapsed or refractory chronic lymphocytic leukaemia: analysis of the VENICE-1 multicentre, open-label, single-arm, phase 3b trial. Lancet Oncol. 2024 Apr;25(4):463-473. doi: 10.1016/S1470-2045(24)00070-6. Epub 2024 Mar 8. |
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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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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Participants were enrolled at 59 sites in 19 countries. The primary analysis of results occurred after all participants completed the Week 48 disease assessment, with a data cut-off date of 30 June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venetoclax | Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. In countries where venetoclax was not commercially available, participants who continued to derive benefit after 2 years of treatment could extend their treatment for up to two additional years plus one additional year until the venetoclax extension study was open. |
| 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 | Oct 12, 2020 | Feb 20, 2023 |
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| From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Overall Response Rate (ORR) - Primary Analysis | Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met:
In addition at least 1 of the following criteria must be met:
PR must have been confirmed at least 7 weeks later. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Duration of Overall Response (DOR) - Primary Analysis | Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Time to Progression (TTP) - Primary Analysis | Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Progression-Free Survival (PFS) - Primary Analysis | Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Overall Survival (OS) - Primary Analysis | Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) | The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess health-related quality of life (HRQoL) and leukemia-specific symptoms using a core set of questions (Functional Assessment of Cancer Therapy-General; FACT-G), and a cancer site-specific leukemia subscale. Questions are scored on a scale from 0 (not at all) to 4 (very much). FACT-G consists of 27 general items divided into 4 primary HRQoL domains: Physical Well-being (PWB; 7 items; score range 0-28), Social/Family Well-being (SWB; 7 items; score range 0-28), Emotional Well-being (EWB; 6 items; score range 0-24), Functional Well-being (FWB; 7 items; score range 0-28). The leukemia subscale consists of 17 items (score range 0-68) that assess patient concerns relating to leukemia. Three summary scales were calculated: FACT-Trial Outcome Index composed of the PWB, FWB, and leukemia subscale (score range 0-124); FACT-G (score range 0-108) and the FACT-Leu Total (range 0-176). Higher scores reflect better HRQoL. | Baseline and Weeks 48 and 108 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) | The FACIT-Fatigue questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-Fatigue includes 13 items answered on a 5-point rating scale based on a 7-day recall period. Scores range from 0 to 52, with lower scores reflecting greater fatigue. | Baseline and Weeks 48 and 108 |
| Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score | The EQ-5D-5L is a generic measure of health status consisting of two parts: a descriptive system consisting of 5 items and a visual analog scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participant is asked to rate each dimension on 5 levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). The scores for the 5 dimensions are used to compute a single health utility index score representing the general health status of the individual. The health index score ranges from zero (defined as a health state equivalent to being dead) to 1 (full health). | Baseline and Weeks 48 and 108 |
| Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score | The EQ-5D-5L is a generic measure of health status consisting of two parts, a descriptive system consisting of 5 items and a visual analog scale (VAS). The VAS assesses the participant's self-rated overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). | Baseline and Weeks 48 and 108 |
| From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Final Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Overall Response Rate (ORR) - Final Analysis | Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met:
In addition at least 1 of the following criteria must be met:
PR must have been confirmed at least 7 weeks later. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Duration of Overall Response (DOR) - Final Analysis | Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Time to Progression (TTP) - Final Analysis | Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Progression-Free Survival (PFS) - Final Analysis | Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Overall Survival (OS) - Final Analysis | Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Minimal Residual Disease (MRD) Negativity Rate - Primary Analysis | The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status. | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
| Minimal Residual Disease (MRD) Negativity Rate - Final Analysis | The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status. | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
| Baltimore |
| Maryland |
| 21229 |
| United States |
| Hackensack Univ Med Ctr /ID# 151574 | Hackensack | New Jersey | 07601 | United States |
| Utah Cancer Specialists /ID# 151604 | Salt Lake City | Utah | 84106 | United States |
| Cancer Care Northwest /ID# 151605 | Spokane | Washington | 99202 | United States |
| West Virginia Univ School Med /ID# 151602 | Morgantown | West Virginia | 26506 | United States |
| LKH-Univ. Klinikum Graz /ID# 147547 | Graz | 8036 | Austria |
| LKH Salzburg and Paracelsus /ID# 147549 | Salzburg | 5020 | Austria |
| Hanusch Krankenhaus der WGKK /ID# 147548 | Vienna | 1140 | Austria |
| Cliniques Universitaires Saint Luc /ID# 147388 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| UZ Leuven /ID# 147387 | Leuven | 3000 | Belgium |
| BC Cancer Agency /ID# 153091 | Vancouver | British Columbia | V5Z 1L3 | Canada |
| Qe Ii Hsc /Id# 147460 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Juravinski Cancer Clinic /ID# 149152 | Hamilton | Ontario | L8V 1C3 | Canada |
| Sunnybrook Health Sciences Ctr /ID# 147462 | Toronto | Ontario | M4N 3M5 | Canada |
| CHU de Quebec-Universite Laval /ID# 150299 | Québec | Quebec | G1R 2J6 | Canada |
| Herlev Hospital /ID# 150183 | Herlev | Capital Region | 2730 | Denmark |
| Aarhus University Hospital /ID# 147409 | Aarhus N | Central Jutland | 8200 | Denmark |
| Turku University Hospital /ID# 147551 | Turku | 20520 | Finland |
| CHU Dupuytren /ID# 147552 | Limoges | Franche-Comte | 87042 | France |
| CHU de la miletrie /ID# 147484 | Poitiers | Poitou-Charentes | 86021 | France |
| Institut Bergonie /ID# 147482 | Bordeaux | 33076 | France |
| CHRU de Brest - Hopital Morvan /ID# 147485 | Brest | 29200 | France |
| clinique Sainte Anne /ID# 147556 | Strasbourg | 67085 | France |
| Onkologische Schwerpunktpraxis /ID# 147516 | Berlin | 10707 | Germany |
| Cent fuer Haematologie und Onk /ID# 147511 | Frankfurt | 60389 | Germany |
| OncoResearch Lerchenfeld GmbH /ID# 164044 | Hamburg | 22081 | Germany |
| Mannheimer Onkologiepraxis /ID# 147512 | Mannheim | 68161 | Germany |
| Staedt. Klinikum Schwabing /ID# 147510 | Munich | 80804 | Germany |
| General Hospital of Athens Laiko /ID# 147517 | Athens | Attica | 115 27 | Greece |
| G. Papanikolaou Hospital /ID# 147518 | Thessaloniki | 57010 | Greece |
| St. James's Hospital /ID# 147519 | Dublin | Dublin | D08 E9P6 | Ireland |
| Beaumont Hospital /ID# 147522 | Dublin | D09 XR63 | Ireland |
| Tel Aviv Sourasky Medical Ctr /ID# 151624 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Galilee Medical Center /ID# 159971 | Nahariya | 22100 | Israel |
| Sheba Medical Center /ID# 147509 | Ramat Gan | 5262100 | Israel |
| A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505 | Bologna | Emilia-Romagna | 40138 | Italy |
| AP Romano Umberto I /ID# 147500 | Rome | Lazio | 00161 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 147503 | Milan | Lombardy | 20162 | Italy |
| Ospedale San Raffaele IRCCS /ID# 147504 | Milan | 20132 | Italy |
| AO Maggiore della Carita /ID# 147499 | Novara | 28100 | Italy |
| Academisch Medisch Centrum /ID# 147494 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Albert Schweitzer Ziekenhuis /ID# 147495 | Dordrecht | South Holland | 3318 AT | Netherlands |
| Haukeland University Hospital /ID# 147382 | Bergen | Hordaland | 5021 | Norway |
| Rikshospitalet OUS HF /ID# 201812 | Oslo | 0450 | Norway |
| IPO Lisboa FG, EPE /ID# 147385 | Lisbon | 1099-023 | Portugal |
| IPO Porto FG, EPE /ID# 147389 | Porto | 4200-072 | Portugal |
| Puerto Rico Hematology Oncolog /ID# 150003 | San Juan | 00959 | Puerto Rico |
| Hospital Santa Creu i Sant Pau /ID# 151230 | Barcelona | 08026 | Spain |
| Fundacion Jimenez Diaz /ID# 151231 | Madrid | 28040 | Spain |
| Hosp Univ Puerta de Hierro /ID# 147391 | Majadahonda | 28222 | Spain |
| Hospital Clinico Univ de Salamanca /ID# 147392 | Salamanca | 37007 | Spain |
| Hosp Clin Univ de Valencia /ID# 147396 | Valencia | 46010 | Spain |
| Skanes Universitetssjukhus Lund /ID# 147439 | Lund | Skåne County | 222 41 | Sweden |
| Akademiska Sjukhuset /ID# 150184 | Uppsala | Uppsala County | 751 85 | Sweden |
| Hopitaux Universitaires de Geneve /ID# 147930 | Geneva | Canton of Geneva | 1205 | Switzerland |
| University Hospital Zurich /ID# 157910 | Zurich | Canton of Zurich | 8006 | Switzerland |
| Ospedale Regional Bellinzona e /ID# 151232 | Bellinzona | 6501 | Switzerland |
| Ankara Univ Medical Faculty /ID# 147443 | Ankara | 6100 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty /ID# 156040 | Istanbul | 34093 | Turkey (Türkiye) |
| Vehbi Koc vakfi Amerikan Hasta /ID# 147325 | Istanbul | 34365 | Turkey (Türkiye) |
| Dokuz Eylul University /ID# 147442 | Izmir | 35340 | Turkey (Türkiye) |
| Ondokuz mayis University Facul /ID# 147326 | Samsun | 55139 | Turkey (Türkiye) |
| Blackpool Teaching Hosp NHS /ID# 149581 | Blackpool | FY3 8NR | United Kingdom |
| Univ Hosp Bristol NHS Foundati /ID# 147647 | Bristol | BS2 8EG | United Kingdom |
| Southampton General Hospital /ID# 147646 | Southampton | SO16 6YD | United Kingdom |
| The Royal Wolverhampton NHS Tr /ID# 147945 | Wolverhampton | WV10 0QP | United Kingdom |
| COMPLETED | Completed survival follow up period or beyond 108 weeks of treatment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Venetoclax | Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Geographic Region | Count of Participants | Participants |
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| Prior Treatment With B-cell Receptor Inhibitor (BCRi) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | All enrolled participants treated with at least one dose of venetoclax who had not previously received treatment with BCRi | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | All enrolled participants treated with at least one dose of venetoclax who were previously treated with BCRi | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Overall Response Rate (ORR) - Primary Analysis | Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met:
In addition at least 1 of the following criteria must be met:
PR must have been confirmed at least 7 weeks later. | All enrolled participants treated with at least one dose of venetoclax | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Duration of Overall Response (DOR) - Primary Analysis | Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date. | Enrolled participants treated with at least one dose of venetoclax who had an overall response of CR, CRi, nPR, or confirmed PR. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Time to Progression (TTP) - Primary Analysis | Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Progression-Free Survival (PFS) - Primary Analysis | Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Overall Survival (OS) - Primary Analysis | Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) | The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess health-related quality of life (HRQoL) and leukemia-specific symptoms using a core set of questions (Functional Assessment of Cancer Therapy-General; FACT-G), and a cancer site-specific leukemia subscale. Questions are scored on a scale from 0 (not at all) to 4 (very much). FACT-G consists of 27 general items divided into 4 primary HRQoL domains: Physical Well-being (PWB; 7 items; score range 0-28), Social/Family Well-being (SWB; 7 items; score range 0-28), Emotional Well-being (EWB; 6 items; score range 0-24), Functional Well-being (FWB; 7 items; score range 0-28). The leukemia subscale consists of 17 items (score range 0-68) that assess patient concerns relating to leukemia. Three summary scales were calculated: FACT-Trial Outcome Index composed of the PWB, FWB, and leukemia subscale (score range 0-124); FACT-G (score range 0-108) and the FACT-Leu Total (range 0-176). Higher scores reflect better HRQoL. | All enrolled participants treated with at least one dose of venetoclax with available data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Weeks 48 and 108 |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) | The FACIT-Fatigue questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-Fatigue includes 13 items answered on a 5-point rating scale based on a 7-day recall period. Scores range from 0 to 52, with lower scores reflecting greater fatigue. | All enrolled participants treated with at least one dose of venetoclax with available data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Weeks 48 and 108 |
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| Secondary | Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score | The EQ-5D-5L is a generic measure of health status consisting of two parts: a descriptive system consisting of 5 items and a visual analog scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participant is asked to rate each dimension on 5 levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). The scores for the 5 dimensions are used to compute a single health utility index score representing the general health status of the individual. The health index score ranges from zero (defined as a health state equivalent to being dead) to 1 (full health). | All enrolled participants treated with at least one dose of venetoclax with available data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Weeks 48 and 108 |
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| Secondary | Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score | The EQ-5D-5L is a generic measure of health status consisting of two parts, a descriptive system consisting of 5 items and a visual analog scale (VAS). The VAS assesses the participant's self-rated overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). | All enrolled participants treated with at least one dose of venetoclax with available data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Weeks 48 and 108 |
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| Other Pre-specified | Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Final Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | All enrolled participants treated with at least one dose of venetoclax who had not previously received treatment with BCRi | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Final Analysis | Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following:
CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity. | All enrolled participants treated with at least one dose of venetoclax who were previously treated with BCRi | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Overall Response Rate (ORR) - Final Analysis | Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met:
In addition at least 1 of the following criteria must be met:
PR must have been confirmed at least 7 weeks later. | All enrolled participants treated with at least one dose of venetoclax | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Duration of Overall Response (DOR) - Final Analysis | Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date. | Enrolled participants treated with at least one dose of venetoclax who had an overall response of CR, CRi, nPR, or confirmed PR. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Time to Progression (TTP) - Final Analysis | Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Progression-Free Survival (PFS) - Final Analysis | Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Overall Survival (OS) - Final Analysis | Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | Enrolled participants treated with at least one dose of venetoclax | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
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| Other Pre-specified | Minimal Residual Disease (MRD) Negativity Rate - Primary Analysis | The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status. | All enrolled participants who received at least one dose of venetoclax | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. |
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| Other Pre-specified | Minimal Residual Disease (MRD) Negativity Rate - Final Analysis | The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status. | All enrolled participants who received at least one dose of venetoclax | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months. |
|
|
All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Not provided
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 | Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years. | 70 | 258 | 136 | 258 | 246 | 258 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| APLASIA PURE RED CELL | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| GRANULOMATOUS LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| INTRAVASCULAR HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| BIFASCICULAR BLOCK | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| HYDROCELE | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DEAFNESS NEUROSENSORY | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| RECTAL PERFORATION | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 24.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MUCOSAL HAEMORRHAGE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 24.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 24.1 | Systematic Assessment |
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| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| BILIARY COLIC | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| GALLBLADDER NECROSIS | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| BRONCHIOLITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| ENDOPHTHALMITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| OSTEOMYELITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| TONSILLITIS BACTERIAL | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HAEMATOMA MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ADENOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| ADRENAL ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| CHRONIC LYMPHOCYTIC LEUKAEMIA TRANSFORMATION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| DIFFUSE LARGE B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| INFECTED NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| SKIN NEOPLASM BLEEDING | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| READING DISORDER | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| BLADDER MASS | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PROSTATIC PAIN | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PHARYNGEAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PHARYNGEAL SWELLING | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PARANEOPLASTIC PEMPHIGUS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ANEURYSM | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| AORTIC INTRAMURAL HAEMATOMA | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.1 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2018 | Mar 30, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| C538045 | Chromosome 17 deletion |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
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| Missing |
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| Rest of the World |
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