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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004027-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion.
This study was designed to enroll approximately 150 participants in 2 cohorts: a main cohort of approximately 100 participants, and a safety expansion (SE) cohort of approximately 50 participants. The primary objective of the main cohort was to evaluate the efficacy of ABT-199 monotherapy in participants with R/R CLL harboring the 17p deletion. The primary objective of the safety expansion cohort was to evaluate the safety of ABT-199 in approximately 50 participants with R/R CLL harboring 17p deletion treated per updated tumor lysis syndrome (TLS) prophylaxis and management measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Cohort | Experimental | Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. |
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| Safety Expansion Cohort | Experimental | Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-199 (Main Cohort) | Drug | Participants received a test dose of ABT-199 of ≤ 20 mg on Week 1 Day 1 of the Lead-In Period. For those with significant electrolyte and/or lymphocyte changes within 24 hours of the first dose, the 20 mg dose was maintained for 7 days with escalation to 50 mg on Week 2 Day 1. If none of the electrolyte and/or lymphocyte changes occurred within 24 hours from ABT-199 20 mg dose administration, the participant was dose-escalated to 50 mg on Week 1 Day 2. After the first dose of 50 mg, if no laboratory abnormalities occurred, the participant remained on the 50 mg dose through Week 1. After receiving the 50 mg dose for approximately 1 week (6 to 7 days), the following dose escalation proceeded with weekly increases in dose: → 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose), as tolerated. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Main Cohort) | The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort. | Up to 36 weeks |
| Number of Participants With Adverse Events (Safety Expansion Cohort) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From the first dose of study drug until 30 days following last dose of study drug (up to 69 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) (Safety Expansion Cohort) | The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. |
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Inclusion Criteria:
Participant must be greater than or equal to 18 years of age.
Participant must have diagnosis of chronic lymphocytic leukemia (CLL) that meets published 2008 Modified IWCLL NCI-WG (International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group) Guidelines.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Participant must have adequate bone marrow function at Screening as follows:
Participant must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:
For participants at high risk of tumor lysis syndrome a pre-approval by the AbbVie medical monitor is required prior to enrollment.
Exclusion Criteria:
Participant has undergone an allogeneic stem cell transplant.
Participant has developed Richter's transformation confirmed by biopsy.
Participant has prolymphocytic leukemia.
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 previously received ABT-199.
Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
Participant has received any of the following within 14 days or 5 half-lives as applicable prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
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 |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center - North Campus /ID# 96748 | Tucson | Arizona | 85719-1478 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27178240 | Background | Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Bottcher S, Mobasher M, Zhu M, Desai M, Chyla B, Verdugo M, Enschede SH, Cerri E, Humerickhouse R, Gordon G, Hallek M, Wierda WG. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016 Jun;17(6):768-778. doi: 10.1016/S1470-2045(16)30019-5. Epub 2016 May 10. | |
| 38290108 |
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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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Cohort | Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. |
| FG001 | Safety Expansion Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2017 | Oct 6, 2021 |
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| ABT-199 (Safety Expansion Cohort) | Drug | Participants received an initial dose of ABT-199 of 20 mg on Week 1 Day 1 of the Lead-In Period. If one or more electrolyte changes (from the 0 hr measurement prior to dosing) suggestive of laboratory tumor lysis syndrome (LTLS) or clinical TLS (CTLS) occurred within 24 hours of the 20 mg dose, no additional doses were administered until resolution. Upon resolution of laboratory abnormalities, the 20 mg dose was continued through Week 1. If no significant findings suggestive of clinical or laboratory TLS occurred within 24 hours, the 20 mg dose was continued through Week 1 Day 7, and escalated to a dose of 50 mg on Week 2 Day 1. Those who had drug interruptions may have been allowed to escalate to and be maintained at 50 mg for 1 week after they had been on a 20 mg dose for at least 1 week (5 - 7 days). After a week at 50 mg, weekly dose escalations were implemented as follows: 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose) as tolerated. |
|
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| Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Complete Remission (CR) Rate | Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Partial Remission (PR) Rate | PR rate was defined as the proportion of participants who achieved a nodular partial remission (nPR) or PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a nPR or PR were considered to be non-responders in the calculation of PR rate. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Duration of Overall Response | Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Progression-free Survival | Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Event-free Survival | Event-free survival (EFS) was defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy. If the specified event (disease progression, death, start of a new anti-leukemic treatment) did not occur, participants were censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Time to Progression | Time to progression (TTP) was defined as the number of days from the date of first dose to the date of earliest disease progression. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant did not experience disease progression, then the data was censored at the date of last available disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Time to First Response | Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Time to 50% Reduction in Absolute Lymphocyte Count | Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC > 5 × 10^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| Overall Survival | Overall survival (OS) was defined as number of days from the date of first dose to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. | Up to the data cutoff date of 15 December 2020, approximately 7.5 years of follow-up |
| Percentage of Participants Who Moved on to Stem Cell Transplant | The percentage of participants who moved on to stem cell transplant was summarized. | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| City of Hope /ID# 112875 |
| Duarte |
| California |
| 91010 |
| United States |
| Moore UC San Diego Cancer Center /ID# 91793 | La Jolla | California | 92093 | United States |
| Stanford University School of Med /ID# 105117 | Stanford | California | 94305-2200 | United States |
| Georgetown University Hospital /ID# 96954 | Washington D.C. | District of Columbia | 20007 | United States |
| Northwestern University Feinberg School of Medicine /ID# 92499 | Chicago | Illinois | 60611-2927 | United States |
| The University of Chicago Medical Center /ID# 96960 | Chicago | Illinois | 60637-1443 | United States |
| Ingalls Memorial Hosp /ID# 92497 | Harvey | Illinois | 60426 | United States |
| Dana-Farber Cancer Institute /ID# 92494 | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System /ID# 97795 | Detroit | Michigan | 48202 | United States |
| Hackensack Univ Med Ctr /ID# 92500 | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey /ID# 92513 | New Brunswick | New Jersey | 08903 | United States |
| Columbia Univ Medical Center /ID# 103835 | New York | New York | 10032-3725 | United States |
| Columbia Univ Medical Center /ID# 94716 | New York | New York | 10032-3725 | United States |
| Cleveland Clinic Main Campus /ID# 92495 | Cleveland | Ohio | 44195 | United States |
| University of Texas MD Anderson Cancer Center /ID# 92521 | Houston | Texas | 77030 | United States |
| Royal North Shore Hospital /ID# 98836 | St Leonards | New South Wales | 2065 | Australia |
| John Fawkner Private Hospital /ID# 98835 | Coburg | Victoria | 3058 | Australia |
| Peter MacCallum Cancer Ctr /ID# 91795 | Melbourne | Victoria | 3000 | Australia |
| Royal Melbourne Hospital /ID# 91794 | Parkville | Victoria | 3050 | Australia |
| Duplicate_Jewish General Hospital /ID# 99476 | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Lyon Sud /ID# 98839 | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
| Hopital Pitie Salpetriere /ID# 98842 | Paris | 75651 | France |
| Centre Henri Becquerel /ID# 98838 | Rouen | 76038 | France |
| Hopital Avicenne - APHP /ID# 98840 | Bobigny | ÃŽle-de-France Region | 93000 | France |
| Universitaetsklinik Heidelberg /ID# 98845 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Uniklinik Koeln /ID# 98847 | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 113235 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitaetsklinikum Ulm /ID# 92533 | Ulm | Thuringia | 89081 | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 113256 | Dresden | 01307 | Germany |
| Universitaetsklinikum Freiburg /ID# 113276 | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsmedizin Goettingen /ID# 113258 | Göttingen | 37075 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 113236 | Mainz | 55131 | Germany |
| Muenchen Klinik Schwabing /ID# 113275 | München | 80804 | Germany |
| SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849 | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 98848 | Lublin | Lublin Voivodeship | 20-081 | Poland |
| Szpital Wojewodzki w Opolu /ID# 102855 | Opole | Opole Voivodeship | 46-020 | Poland |
| Leicester Royal Infirmary /ID# 98865 | Leicester | England | LE1 5WW | United Kingdom |
| The Royal Bournemouth Hospital /ID# 118975 | Bournemouth | BH7 7DW | United Kingdom |
| Addenbrookes Hospital /ID# 119977 | Cambridge | CB2 0SP | United Kingdom |
| St. James University Hospital /ID# 98863 | Leeds | LS9 7TF | United Kingdom |
| Royal Liverpool and Broadgreen /ID# 98860 | Liverpool | L7 8XP | United Kingdom |
| St Bartholomew's Hospital, Bar /ID# 98862 | London | EC1A 7BE | United Kingdom |
| King's College Hospital NHS Foundation Trust /ID# 119975 | London | SE5 9RS | United Kingdom |
| The Christie Hospital /ID# 98864 | Manchester | M20 4BX | United Kingdom |
| Oxford Univ Hosp NHS Trust /ID# 119976 | Oxford | OX3 7LE | United Kingdom |
| Derriford Hospital /ID# 118335 | Plymouth | PL6 8DH | United Kingdom |
| Royal Marsden Hospital /ID# 98861 | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Stilgenbauer S, Tausch E, Roberts AW, Davids MS, Eichhorst B, Hallek M, Hillmen P, Schneider C, Schetelig J, Bottcher S, Kater AP, Jiang Y, Boyer M, Popovic R, Ghanim MT, Moran M, Sinai WJ, Wang X, Mukherjee N, Chyla B, Wierda WG, Seymour JF. Six-year follow-up and subgroup analyses of a phase 2 trial of venetoclax for del(17p) chronic lymphocytic leukemia. Blood Adv. 2024 Apr 23;8(8):1992-2004. doi: 10.1182/bloodadvances.2023011741. |
| 31023700 | Derived | Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25. |
| 29715056 | Derived | Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, Jurczak W, Mulligan SP, Schuh A, Assouline S, Wendtner CM, Roberts AW, Davids MS, Bloehdorn J, Munir T, Bottcher S, Zhou L, Salem AH, Desai M, Chyla B, Arzt J, Kim SY, Verdugo M, Gordon G, Hallek M, Wierda WG. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018 Jul 1;36(19):1973-1980. doi: 10.1200/JCO.2017.76.6840. Epub 2018 May 1. |
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
| COMPLETED |
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| NOT COMPLETED |
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All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Main Cohort | Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. |
| BG001 | Safety Expansion Cohort | Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (Main Cohort) | The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort. | The first 70 participants who were treated with ABT-199 in the Main Cohort | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 36 weeks |
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| Primary | Number of Participants With Adverse Events (Safety Expansion Cohort) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | All treated participants in the Safety Expansion Cohort | Posted | Count of Participants | Participants | No | From the first dose of study drug until 30 days following last dose of study drug (up to 69 months) |
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| Secondary | Overall Response Rate (ORR) (Safety Expansion Cohort) | The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. | All treated participants in the Safety Expansion Cohort | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
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| Secondary | Complete Remission (CR) Rate | Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate. | All treated participants in the Main Cohort and the Safety Expansion Cohort | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
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| Secondary | Partial Remission (PR) Rate | PR rate was defined as the proportion of participants who achieved a nodular partial remission (nPR) or PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a nPR or PR were considered to be non-responders in the calculation of PR rate. | All treated participants in the Main Cohort and the Safety Expansion Cohort | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
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| Secondary | Duration of Overall Response | Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis. | All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data | Posted | Median | 95% Confidence Interval | months | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
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| Secondary | Progression-free Survival | Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | All treated participants in the Main Cohort and the Safety Expansion Cohort with available data | Posted | Median | 95% Confidence Interval | months | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
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| Secondary | Event-free Survival | Event-free survival (EFS) was defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy. If the specified event (disease progression, death, start of a new anti-leukemic treatment) did not occur, participants were censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | All treated participants in the Main Cohort and the Safety Expansion Cohort with available data | Posted | Median | 95% Confidence Interval | months | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
|
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| Secondary | Time to Progression | Time to progression (TTP) was defined as the number of days from the date of first dose to the date of earliest disease progression. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant did not experience disease progression, then the data was censored at the date of last available disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day. | All treated participants in the Main Cohort and the Safety Expansion Cohort with available data | Posted | Median | 95% Confidence Interval | months | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Response | Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis. | All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data | Posted | Mean | 95% Confidence Interval | months | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 50% Reduction in Absolute Lymphocyte Count | Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC > 5 × 10^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis. | All treated participants with a baseline of ALC > 5 × 10^9 /L, a 50% reduction in ALC, and available data | Posted | Mean | 95% Confidence Interval | weeks | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) was defined as number of days from the date of first dose to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. | All treated participants with available data | Posted | Median | 95% Confidence Interval | months | Up to the data cutoff date of 15 December 2020, approximately 7.5 years of follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Moved on to Stem Cell Transplant | The percentage of participants who moved on to stem cell transplant was summarized. | All treated participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up |
|
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 80 months for the Main Cohort and up to 69 months for the Safety Expansion Cohort.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
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 | Main Cohort | Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. | 62 | 107 | 78 | 107 | 103 | 107 |
| EG001 | Safety Expansion Cohort | Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. | 19 | 51 | 34 | 51 | 50 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMORRHAGIC DIATHESIS | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| IMMUNE THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERTENSIVE HEART DISEASE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ATRIAL SEPTAL DEFECT | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYDROCELE | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INTESTINAL PSEUDO-OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TOOTH LOSS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOTHERMIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ADENOVIRUS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| BETA HAEMOLYTIC STREPTOCOCCAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| HERPES ZOSTER CUTANEOUS DISSEMINATED | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| IMPETIGO | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFECTED SKIN ULCER | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| METAPNEUMOVIRUS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PARAINFLUENZAE VIRUS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY MYCOSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| RHINOVIRUS INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SCROTAL ABSCESS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SCROTAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ANASTOMOTIC LEAK | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD GLUCOSE FLUCTUATION | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| CANDIDA TEST POSITIVE | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| ESCHERICHIA TEST POSITIVE | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACOUSTIC NEUROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHIAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| CHRONIC LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| UTERINE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PROGRESSIVE SUPRANUCLEAR PALSY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BLADDER DISORDER | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CYSTITIS NONINFECTIVE | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VAGINAL PROLAPSE | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN HAEMORRHAGE | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.1 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2018 | Oct 6, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| C538045 | Chromosome 17 deletion |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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
| Male |
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| Black |
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| Asian |
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| American Indian/Alaska Native |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Multi race |
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