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A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor (VENICE I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02756611
Recruitment Status : Active, not recruiting
First Posted : April 29, 2016
Results First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Intervention Drug: Venetoclax
Enrollment 258
Recruitment Details Participants were enrolled at 59 sites in 19 countries. This study is currently ongoing. Results are reported up to the primary analysis data cut-off date of 30 June 2019, which occurred after all participants completed the Week 48 disease assessment.
Pre-assignment Details  
Arm/Group Title Venetoclax
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 258
Completed [1] 2
Not Completed 256
Reason Not Completed
Death             39
Withdrawal by Subject             1
Lost to Follow-up             2
Other             7
Missing             2
Active on Study             205
[1]
Completed survival follow up period
Arm/Group Title Venetoclax
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants
67.7  (9.04)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
< 65 years
94
  36.4%
>= 65 years
164
  63.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
Female
78
  30.2%
Male
180
  69.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
Hispanic or Latino
9
   3.5%
Not Hispanic or Latino
248
  96.1%
Unknown or Not Reported
1
   0.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
White
252
  97.7%
Black or African American
3
   1.2%
Asian
2
   0.8%
Missing
1
   0.4%
Geographic Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
Europe
161
  62.4%
North America
28
  10.9%
Rest of the World
69
  26.7%
Prior Treatment With B-cell Receptor Inhibitor (BCRi)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
BCRi-naive
191
  74.0%
BCRi-exposed
67
  26.0%
1.Primary Outcome
Title Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy
Hide Description

Complete remission rate is defined as the percentage of participants achieving a complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response 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:

  • Peripheral blood lymphocytes <4000/μL
  • Absence of lymphadenopathy by physical examination and computed tomography scan
  • No hepatomegaly or splenomegaly by physical examination
  • Absence of disease or constitutional symptoms (unexplained fevers >38°C, drenching night sweats, >10% weight loss in last 6 months)
  • Blood counts above the following:

    • Neutrophils >1500/μL
    • Platelets >100,000/μL
    • Hemoglobin >110 g/L
  • Bone marrow at least normocellular for age, <30% lymphocytes

CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of venetoclax who had not previously received treatment with BCRi
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.1
(28.3 to 42.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venetoclax
Comments The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be > 6%. If the p-value for this test was < 0.025, the null hypothesis would be rejected.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Complete Remission Rate in Participants Previously Treated With BCRi Therapy
Hide Description

Complete remission rate is defined as the percentage of participants achieving a complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response 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:

  • Peripheral blood lymphocytes <4000/μL
  • Absence of lymphadenopathy by physical examination and computed tomography scan
  • No hepatomegaly or splenomegaly by physical examination
  • Absence of disease or constitutional symptoms (unexplained fevers >38°C, drenching night sweats, >10% weight loss in last 6 months)
  • Blood counts above the following:

    • Neutrophils >1500/μL
    • Platelets >100,000/μL
    • Hemoglobin >110 g/L
  • Bone marrow at least normocellular for age, <30% lymphocytes

CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of venetoclax who were previously treated with BCRi
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.4
(15.5 to 37.5)
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description

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 as assessed by investigator.

CR and CRi are defined above. nPR is defined as participants with CR but for whom bone marrow nodules could be identified histologically.

For PR at least 2 of the following must be met:

  • ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value
  • ≥ 50% reduction in lymphadenopathy
  • ≥ 50% reduction in the size of the liver and/or spleen (if abnormal prior to therapy) and at least one of the following criteria must be met:
  • Neutrophils > 1,500/μL or ≥ 50% improvement over baseline
  • Platelets > 100,000/μL or ≥ 50% improvement over baseline
  • Hemoglobin > 11.0 g/dL or ≥ 50% improvement over baseline without transfusions or exogenous growth factors.

PR must be confirmed at least 7 weeks later.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of venetoclax
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.8
(74.4 to 84.6)
4.Secondary Outcome
Title Duration of Overall Response (DoR)
Hide Description Duration of response is defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) is objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding their data was censored at the date of the last available disease assessment prior to the data cutoff date.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants treated with at least one dose of venetoclax who had an overall response of CR, CRi, nPR, or confirmed PR.
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 205
Median (95% Confidence Interval)
Unit of Measure: months
25.2
(23.0 to 25.2)
5.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to progression is 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants treated with at least one dose of venetoclax
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Median (95% Confidence Interval)
Unit of Measure: months
30.5
(29.6 to 30.5)
6.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants treated with at least one dose of venetoclax
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Median (95% Confidence Interval)
Unit of Measure: months
30.5
(28.6 to 30.5)
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (time to death) will be defined as the number of days from the first dose date of venetoclax to the date of death. If a participant had not died their 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants treated with at least one dose of venetoclax
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of events
8.Secondary Outcome
Title Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu)
Hide Description The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess patient health-related quality of life (HRQoL) and leukemia-specific symptoms.
Time Frame Up to Week 108
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
Hide Description The FACIT-F questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-F has 13 items answered on a 5-point rating scale based on a 7-day recall period.
Time Frame Up to Week 108
Outcome Measure Data Not Reported
10.Secondary Outcome
Title EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
Hide Description Five items in the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) are rated on 5 levels of severity.
Time Frame Up to Week 108
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Minimal Residual Disease (MRD) Negativity Rate
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of venetoclax
Arm/Group Title Venetoclax
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Peripheral blood
39.9
(33.9 to 46.2)
Bone marrow
9.7
(6.4 to 14.0)
Time Frame From the first dose of venetoclax and up to 30 days after the last dose of venetoclax, up to the data cut-off date of 30 June 2019. Median (minimum, maximum) duration of treatment was 90.7 (0.1, 145.6) weeks. Mortality data are reported up to the end of study, as of the data cut-off date.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Venetoclax
Hide Arm/Group Description 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. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 2 additional years.
All-Cause Mortality
Venetoclax
Affected / at Risk (%)
Total   42/258 (16.28%)    
Hide Serious Adverse Events
Venetoclax
Affected / at Risk (%) # Events
Total   121/258 (46.90%)    
Blood and lymphatic system disorders   
Anaemia  1  4/258 (1.55%)  4
Aplasia pure red cell  1  1/258 (0.39%)  1
Autoimmune haemolytic anaemia  1  3/258 (1.16%)  6
Febrile neutropenia  1  15/258 (5.81%)  18
Haemolysis  1  1/258 (0.39%)  1
Intravascular haemolysis  1  1/258 (0.39%)  2
Leukocytosis  1  1/258 (0.39%)  1
Neutropenia  1  4/258 (1.55%)  4
Pancytopenia  1  2/258 (0.78%)  2
Thrombocytopenia  1  3/258 (1.16%)  4
Cardiac disorders   
Aortic valve stenosis  1  1/258 (0.39%)  1
Atrial fibrillation  1  1/258 (0.39%)  1
Cardiac failure  1  2/258 (0.78%)  2
Cardiac failure congestive  1  2/258 (0.78%)  2
Coronary artery disease  1  1/258 (0.39%)  1
Congenital, familial and genetic disorders   
Hydrocele  1  1/258 (0.39%)  1
Ear and labyrinth disorders   
Deafness neurosensory  1  1/258 (0.39%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/258 (0.39%)  1
Ascites  1  1/258 (0.39%)  1
Diarrhoea  1  5/258 (1.94%)  5
Diverticulum intestinal haemorrhagic  1  1/258 (0.39%)  1
Inguinal hernia  1  2/258 (0.78%)  2
Intestinal obstruction  1  1/258 (0.39%)  1
Rectal perforation  1  1/258 (0.39%)  1
Vomiting  1  1/258 (0.39%)  1
General disorders   
Chest pain  1  1/258 (0.39%)  1
Death  1  1/258 (0.39%)  1
Fatigue  1  1/258 (0.39%)  1
General physical health deterioration  1  1/258 (0.39%)  1
Malaise  1  1/258 (0.39%)  1
Mucosal haemorrhage  1  1/258 (0.39%)  1
Pyrexia  1  9/258 (3.49%)  9
Hepatobiliary disorders   
Bile duct stone  1  1/258 (0.39%)  1
Biliary colic  1  1/258 (0.39%)  1
Cholangitis  1  1/258 (0.39%)  1
Cholelithiasis  1  1/258 (0.39%)  1
Gallbladder necrosis  1  1/258 (0.39%)  1
Hepatic cirrhosis  1  1/258 (0.39%)  1
Immune system disorders   
Drug hypersensitivity  1  1/258 (0.39%)  1
Hypersensitivity  1  1/258 (0.39%)  1
Infections and infestations   
Abscess limb  1  1/258 (0.39%)  1
Arthritis bacterial  1  1/258 (0.39%)  1
Bronchiolitis  1  1/258 (0.39%)  1
Bronchitis  1  2/258 (0.78%)  2
Cellulitis  1  2/258 (0.78%)  2
Diverticulitis  1  1/258 (0.39%)  1
Endophthalmitis  1  1/258 (0.39%)  1
Escherichia infection  1  1/258 (0.39%)  2
Gastroenteritis  1  2/258 (0.78%)  2
Herpes zoster  1  2/258 (0.78%)  2
Influenza  1  2/258 (0.78%)  2
Localised infection  1  1/258 (0.39%)  1
Lower respiratory tract infection  1  3/258 (1.16%)  3
Neutropenic sepsis  1  1/258 (0.39%)  1
Pneumonia  1  19/258 (7.36%)  27
Pneumonia bacterial  1  1/258 (0.39%)  1
Progressive multifocal leukoencephalopathy  1  1/258 (0.39%)  1
Pyelonephritis  1  1/258 (0.39%)  1
Respiratory syncytial virus infection  1  2/258 (0.78%)  2
Respiratory tract infection  1  1/258 (0.39%)  1
Sepsis  1  1/258 (0.39%)  1
Septic shock  1  2/258 (0.78%)  2
Skin infection  1  1/258 (0.39%)  1
Staphylococcal infection  1  1/258 (0.39%)  1
Tonsillitis  1  1/258 (0.39%)  1
Upper respiratory tract infection  1  2/258 (0.78%)  2
Urosepsis  1  1/258 (0.39%)  1
Injury, poisoning and procedural complications   
Brain contusion  1  1/258 (0.39%)  1
Clavicle fracture  1  1/258 (0.39%)  1
Contusion  1  1/258 (0.39%)  1
Fall  1  2/258 (0.78%)  4
Femoral neck fracture  1  1/258 (0.39%)  1
Head injury  1  1/258 (0.39%)  1
Hip fracture  1  1/258 (0.39%)  1
Infusion related reaction  1  1/258 (0.39%)  1
Pelvic fracture  1  1/258 (0.39%)  1
Investigations   
Aspartate aminotransferase increased  1  3/258 (1.16%)  3
Blood bilirubin increased  1  1/258 (0.39%)  1
Blood creatinine increased  1  2/258 (0.78%)  2
Blood lactate dehydrogenase increased  1  4/258 (1.55%)  4
Blood phosphorus increased  1  1/258 (0.39%)  1
Blood potassium increased  1  3/258 (1.16%)  3
General physical condition abnormal  1  1/258 (0.39%)  1
Platelet count decreased  1  1/258 (0.39%)  1
Weight decreased  1  2/258 (0.78%)  2
Metabolism and nutrition disorders   
Cachexia  1  1/258 (0.39%)  1
Diabetes mellitus  1  1/258 (0.39%)  1
Fluid retention  1  1/258 (0.39%)  1
Hyperglycaemia  1  1/258 (0.39%)  1
Hyperkalaemia  1  4/258 (1.55%)  7
Hyperphosphataemia  1  3/258 (1.16%)  4
Hypoglycaemia  1  1/258 (0.39%)  1
Tumour lysis syndrome  1  2/258 (0.78%)  2
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/258 (0.39%)  1
Back pain  1  1/258 (0.39%)  1
Haematoma muscle  1  1/258 (0.39%)  1
Osteoarthritis  1  1/258 (0.39%)  2
Osteoporosis  1  1/258 (0.39%)  1
Pain in extremity  1  1/258 (0.39%)  1
Spinal pain  1  1/258 (0.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenoma benign  1  1/258 (0.39%)  1
Adrenal adenoma  1  1/258 (0.39%)  1
Bladder cancer  1  1/258 (0.39%)  1
Chronic lymphocytic leukaemia transformation  1  1/258 (0.39%)  2
Diffuse large B-cell lymphoma  1  1/258 (0.39%)  1
Infected neoplasm  1  1/258 (0.39%)  1
Lung adenocarcinoma  1  2/258 (0.78%)  2
Lung neoplasm malignant  1  1/258 (0.39%)  1
Myelodysplastic syndrome  1  2/258 (0.78%)  2
Rectal adenocarcinoma  1  1/258 (0.39%)  1
Squamous cell carcinoma  1  1/258 (0.39%)  1
Squamous cell carcinoma of skin  1  1/258 (0.39%)  1
Nervous system disorders   
Ataxia  1  1/258 (0.39%)  1
Dizziness  1  1/258 (0.39%)  1
Facial paralysis  1  1/258 (0.39%)  1
Haemorrhage intracranial  1  1/258 (0.39%)  1
Ischaemic stroke  1  1/258 (0.39%)  1
Metabolic encephalopathy  1  1/258 (0.39%)  1
Sciatica  1  1/258 (0.39%)  1
Somnolence  1  1/258 (0.39%)  1
Subarachnoid haemorrhage  1  1/258 (0.39%)  1
Syncope  1  2/258 (0.78%)  3
Psychiatric disorders   
Confusional state  1  2/258 (0.78%)  3
Depression  1  1/258 (0.39%)  1
Mental status changes  1  1/258 (0.39%)  2
Renal and urinary disorders   
Bladder mass  1  1/258 (0.39%)  1
Urinary incontinence  1  1/258 (0.39%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/258 (0.39%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  2/258 (0.78%)  2
Asthma  1  1/258 (0.39%)  1
Atelectasis  1  1/258 (0.39%)  1
Bronchiectasis  1  1/258 (0.39%)  1
Chronic obstructive pulmonary disease  1  1/258 (0.39%)  1
Cough  1  2/258 (0.78%)  2
Dyspnoea  1  4/258 (1.55%)  4
Dyspnoea exertional  1  1/258 (0.39%)  1
Epistaxis  1  1/258 (0.39%)  1
Oropharyngeal pain  1  1/258 (0.39%)  1
Pharyngeal disorder  1  1/258 (0.39%)  1
Pharyngeal swelling  1  1/258 (0.39%)  1
Pleural effusion  1  3/258 (1.16%)  4
Pneumonitis  1  1/258 (0.39%)  1
Pulmonary embolism  1  1/258 (0.39%)  1
Pulmonary hypertension  1  1/258 (0.39%)  2
Skin and subcutaneous tissue disorders   
Paraneoplastic pemphigus  1  1/258 (0.39%)  1
Rash  1  1/258 (0.39%)  1
Vascular disorders   
Aneurysm  1  1/258 (0.39%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Venetoclax
Affected / at Risk (%) # Events
Total   242/258 (93.80%)    
Blood and lymphatic system disorders   
Anaemia  1  54/258 (20.93%)  77
Neutropenia  1  106/258 (41.09%)  238
Thrombocytopenia  1  51/258 (19.77%)  83
Gastrointestinal disorders   
Abdominal pain  1  17/258 (6.59%)  19
Constipation  1  33/258 (12.79%)  39
Diarrhoea  1  88/258 (34.11%)  153
Nausea  1  67/258 (25.97%)  94
Vomiting  1  19/258 (7.36%)  22
General disorders   
Asthenia  1  30/258 (11.63%)  39
Fatigue  1  38/258 (14.73%)  49
Oedema peripheral  1  13/258 (5.04%)  17
Pyrexia  1  42/258 (16.28%)  53
Infections and infestations   
Influenza  1  14/258 (5.43%)  14
Nasopharyngitis  1  38/258 (14.73%)  57
Upper respiratory tract infection  1  43/258 (16.67%)  60
Urinary tract infection  1  20/258 (7.75%)  29
Investigations   
Neutrophil count decreased  1  28/258 (10.85%)  44
Platelet count decreased  1  19/258 (7.36%)  24
Weight decreased  1  19/258 (7.36%)  21
Metabolism and nutrition disorders   
Decreased appetite  1  23/258 (8.91%)  28
Hyperkalaemia  1  21/258 (8.14%)  31
Hyperphosphataemia  1  20/258 (7.75%)  23
Hyperuricaemia  1  15/258 (5.81%)  15
Hypocalcaemia  1  15/258 (5.81%)  19
Hypokalaemia  1  13/258 (5.04%)  17
Musculoskeletal and connective tissue disorders   
Arthralgia  1  27/258 (10.47%)  31
Back pain  1  28/258 (10.85%)  30
Muscle spasms  1  16/258 (6.20%)  19
Nervous system disorders   
Dizziness  1  18/258 (6.98%)  23
Headache  1  26/258 (10.08%)  28
Psychiatric disorders   
Insomnia  1  23/258 (8.91%)  25
Respiratory, thoracic and mediastinal disorders   
Cough  1  47/258 (18.22%)  56
Dyspnoea  1  20/258 (7.75%)  23
Oropharyngeal pain  1  13/258 (5.04%)  14
Skin and subcutaneous tissue disorders   
Dry skin  1  17/258 (6.59%)  20
Pruritus  1  22/258 (8.53%)  25
Rash  1  18/258 (6.98%)  29
Vascular disorders   
Hypertension  1  22/258 (8.53%)  26
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02756611    
Other Study ID Numbers: M15-550
2015-003667-11 ( EudraCT Number )
First Submitted: April 26, 2016
First Posted: April 29, 2016
Results First Submitted: March 30, 2020
Results First Posted: May 4, 2020
Last Update Posted: May 4, 2020