A Phase 2 Open-Label Study of the Efficacy and Safety of... | NCT02141282 | Trialant
NCT02141282
Sponsor
AbbVie
Status
Completed
Last Update Posted
Dec 19, 2022Actual
Enrollment
127Actual
Phase
Phase 2
Conditions
Chronic Lymphocytic Leukemia
Interventions
Venetoclax
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02141282
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-032
Secondary IDs
Not provided
Brief Title
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Official Title
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03123029Available
Start Date
Sep 10, 2014Actual
Primary Completion Date
Dec 22, 2021Actual
Completion Date
Dec 22, 2021Actual
First Submitted Date
May 12, 2014
First Submission Date that Met QC Criteria
May 15, 2014
First Posted Date
May 19, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 18, 2022
Results First Submitted that Met QC Criteria
Nov 18, 2022
Results First Posted Date
Dec 19, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 18, 2022
Last Update Posted Date
Dec 19, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Roche-Genentech
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Lymphocytic Leukemia
Keywords
Oncology
Chronic Lymphocytic Leukemia
Cancer of the blood and bone marrow
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
127Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABT-199 after ibrutinib therapy
Experimental
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Drug: Venetoclax
ABT-199 after idelalisib therapy
Experimental
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Drug: Venetoclax
ABT-199 after ibrutinib therapy: Expansion Cohort
Experimental
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
Drug: Venetoclax
ABT-199 after idelalisib therapy: Expansion Cohort
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Venetoclax
Drug
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR)
Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR)
DOR is defined as the number of days from the date of first response (complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or partial remission [PR]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
Other Outcomes
Measure
Description
Time Frame
Time to Next Anti-Chronic Lymphocytic Leukemia Treatment (TNNT)
TNNT is defined as the number of days from the date of the first dose of venetoclax to the date of first dose of any non-protocol anti-leukemia therapy (NPT) or death from any cause. For participants who did not take NPT, their data was censored at the last known date to be free of NPT. TTNT was analyzed by Kaplan-Meier methodology.
Collected every 3 months for a period of 5 years after the last participant had enrolled into the study
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria
Participant has relapsed/refractory disease with an indication for treatment
Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI)
Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2
Participant must have adequate bone marrow function at Screening
Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
Exclusion Criteria:
Participant has undergone an allogeneic stem cell transplant within the past year
Participant has developed Richter's transformation confirmed by biopsy
Participant has active and uncontrolled autoimmune cytopenia
Participant has malabsorption syndrome or other condition that precludes enteral route of administration
Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment
Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Safety population: all participants who received at least one dose of venetoclax
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ABT-199 After Ibrutinib Therapy
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 15, 2020
Nov 18, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
Drug: Venetoclax
ABT-199 after ibrutinib therapy
ABT-199 after ibrutinib therapy: Expansion Cohort
ABT-199 after idelalisib therapy
ABT-199 after idelalisib therapy: Expansion Cohort
ABT-199
VENCLEXTA®
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (PD).
TTP was analyzed by Kaplan-Meier (K-M) methodology.
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
Progression-free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
Overall Survival (OS)
OS is defined as the number of days from the date of first dose to the date of death for all dosed participants. 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. OS was estimated using Kaplan-Meier methodology.
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Status
The rate of MRD response is defined as the percentage of participants who had MRD negative status.
Assessed at Week 24, Day 1; after the first Complete Response, Complete Remission with Incomplete Marrow Recovery, or Partial Response; at 12-week interval visits until two consecutive negative MRD levels were reported
Jones JA, Mato AR, Wierda WG, Davids MS, Choi M, Cheson BD, Furman RR, Lamanna N, Barr PM, Zhou L, Chyla B, Salem AH, Verdugo M, Humerickhouse RA, Potluri J, Coutre S, Woyach J, Byrd JC. Venetoclax for chronic lymphocytic leukaemia progressing after ibrutinib: an interim analysis of a multicentre, open-label, phase 2 trial. Lancet Oncol. 2018 Jan;19(1):65-75. doi: 10.1016/S1470-2045(17)30909-9. Epub 2017 Dec 12.
FG001
ABT-199 After Idelalisib Therapy
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
FG002
ABT-199 After Ibrutinib Therapy: Expansion Cohort
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
FG003
ABT-199 After Idelalisib Therapy: Expansion Cohort
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
FG00043 subjects
FG00121 subjects
FG00248 subjects
FG00315 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00043 subjects
FG00121 subjects
FG00248 subjects
FG00315 subjects
Type
Comment
Reasons
Adverse event, not related to progression
FG0008 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
Adverse event, related to progression
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
COVID-19 infection
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0032 subjects
Other, not specified
FG00014 subjects
FG00111 subjects
FG00223 subjects
FG0039 subjects
Progressive disease, Richter's
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Progressive disease per protocol
FG00012 subjects
FG0017 subjects
FG0029 subjects
FG0032 subjects
Stem cell transplant
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Study terminated by Sponsor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Subject non-compliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Withdrew consent
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
All treated participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ABT-199 After Ibrutinib Therapy
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
BG001
ABT-199 After Idelalisib Therapy
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
BG002
ABT-199 After Ibrutinib Therapy: Expansion Cohort
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
BG003
ABT-199 After Idelalisib Therapy: Expansion Cohort
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00043
BG00121
BG00248
BG00315
BG004127
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065.7± 8.74
BG00168.0± 7.26
BG00264.2± 10.72
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG00040
BG00119
BG002
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 (ORR)
Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
Posted
Number
95% Confidence Interval
percentage of participants
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Participants
OG00091
OG00136
Title
Denominators
Categories
Title
Measurements
OG00064.8(54.1 to 74.6)
OG00169.4(51.9 to 83.7)
Secondary
Duration of Response (DOR)
DOR is defined as the number of days from the date of first response (complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or partial remission [PR]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.
All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better
Posted
Median
95% Confidence Interval
months
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Secondary
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (PD).
TTP was analyzed by Kaplan-Meier (K-M) methodology.
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
Posted
Median
95% Confidence Interval
months
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Participants
Secondary
Progression-free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.
All enrolled participants who received venetoclax and had active disease at baseline
Posted
Median
95% Confidence Interval
months
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Participants
Secondary
Overall Survival (OS)
OS is defined as the number of days from the date of first dose to the date of death for all dosed participants. 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. OS was estimated using Kaplan-Meier methodology.
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
Posted
Median
95% Confidence Interval
months
At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Other Pre-specified
Time to Next Anti-Chronic Lymphocytic Leukemia Treatment (TNNT)
TNNT is defined as the number of days from the date of the first dose of venetoclax to the date of first dose of any non-protocol anti-leukemia therapy (NPT) or death from any cause. For participants who did not take NPT, their data was censored at the last known date to be free of NPT. TTNT was analyzed by Kaplan-Meier methodology.
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax
Posted
Median
95% Confidence Interval
months
Collected every 3 months for a period of 5 years after the last participant had enrolled into the study
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Participants
Other Pre-specified
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Status
The rate of MRD response is defined as the percentage of participants who had MRD negative status.
All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax; indeterminate or missing samples were considered MRD positive for the calculation
Posted
Number
95% Confidence Interval
percentage of participants
Assessed at Week 24, Day 1; after the first Complete Response, Complete Remission with Incomplete Marrow Recovery, or Partial Response; at 12-week interval visits until two consecutive negative MRD levels were reported
ID
Title
Description
OG000
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
OG001
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Units
Counts
Participants
Time Frame
All-cause mortality reported from enrollment to 30 d after last dose of study drug; median time on follow up was up to 1694 d for those with ibrutinib-resistant or refractory CLL and up to 1942 d for those with idelalisib-resistant or refractory CLL. TEAEs and SAEs collected from first dose of study drug until 30 d after last dose of study drug; mean duration on study drug was 819.8 d (ibrutinib-resistant or refractory CLL cohorts) and 1151.5 d (idelalisib-resistant or refractory CLL cohorts).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ABT-199 After Ibrutinib Therapy: Main Cohort
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
25
43
35
43
43
43
EG001
ABT-199 After Idelalisib Therapy: Main Cohort
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
9
21
14
21
21
21
EG002
ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort
Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Main Cohort
34
64
49
64
64
64
EG003
ABT-199 After Ibrutinib Therapy: Expansion Cohort
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
17
48
26
48
48
48
EG004
ABT-199 After Idelalisib Therapy: Expansion Cohort
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
4
15
9
15
15
15
EG005
ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort
Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort
21
63
35
63
63
63
EG006
ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
42
91
61
91
91
91
EG007
ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
13
36
23
36
36
36
EG008
All Participants
All participants in the Main and Expansion Cohorts
55
127
84
127
127
127
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected48 at risk
EG0041 events1 affected15 at risk
EG0052 events2 affected63 at risk
EG0061 events1 affected91 at risk
EG0071 events1 affected36 at risk
EG0082 events2 affected127 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected64 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00013 events10 affected43 at risk
EG0011 events1 affected21 at risk
EG00214 events11 affected64 at risk
EG003
HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ANGINA UNSTABLE
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events1 affected21 at risk
EG0022 events1 affected64 at risk
EG003
ATRIAL FLUTTER
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
VENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
EROSIVE OESOPHAGITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
INCARCERATED INGUINAL HERNIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
INTESTINAL ISCHAEMIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
MESENTERIC VEIN THROMBOSIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
MOUTH HAEMORRHAGE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ASTHENIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
DEATH
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
FACIAL PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected64 at risk
EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected64 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected64 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BILE DUCT STONE
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
CYTOKINE RELEASE SYNDROME
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CORYNEBACTERIUM BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
CORYNEBACTERIUM SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ESCHERICHIA BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ESCHERICHIA SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected64 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected64 at risk
EG003
LYMPH GLAND INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PAROTITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0008 events6 affected43 at risk
EG0018 events3 affected21 at risk
EG00216 events9 affected64 at risk
EG003
PNEUMONIA ASPIRATION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PNEUMONIA LEGIONELLA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PNEUMONIA PSEUDOMONAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected64 at risk
EG003
STAPHYLOCOCCAL BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
STREPTOCOCCAL BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected21 at risk
EG0022 events2 affected64 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PELVIC FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
POST PROCEDURAL HAEMATURIA
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected64 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
HYPERVOLAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected64 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BLADDER CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CHRONIC LYMPHOCYTIC LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
HIGH-GRADE B-CELL LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
METASTASES TO MENINGES
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
MUCOEPIDERMOID CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
RICHTER'S SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
SALIVARY GLAND CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
CAUDA EQUINA SYNDROME
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected64 at risk
EG003
HAEMORRHAGE INTRACRANIAL
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
BLADDER OUTLET OBSTRUCTION
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
PROSTATIC OBSTRUCTION
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ASPHYXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
PULMONARY GRANULOMA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
DRUG ERUPTION
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
EOSINOPHILIC CELLULITIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
ORTHOSTATIC HYPOTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00044 events24 affected43 at risk
EG00125 events4 affected21 at risk
EG00269 events28 affected64 at risk
EG00351 events21 affected48 at risk
EG0043 events3 affected15 at risk
EG00554 events24 affected63 at risk
EG00695 events45 affected91 at risk
EG00728 events7 affected36 at risk
EG008123 events52 affected127 at risk
LYMPH NODE PAIN
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00032 events16 affected43 at risk
EG00127 events10 affected21 at risk
EG00259 events26 affected64 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00014 events11 affected43 at risk
EG00124 events6 affected21 at risk
EG00238 events17 affected64 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00010 events7 affected43 at risk
EG0010 events0 affected21 at risk
EG00210 events7 affected64 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0011 events1 affected21 at risk
EG0023 events2 affected64 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00012 events7 affected43 at risk
EG0017 events7 affected21 at risk
EG00219 events14 affected64 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00038 events22 affected43 at risk
EG00118 events9 affected21 at risk
EG00256 events31 affected64 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0013 events3 affected21 at risk
EG0025 events5 affected64 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0012 events1 affected21 at risk
EG0025 events4 affected64 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0013 events3 affected21 at risk
EG0027 events7 affected64 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0010 events0 affected21 at risk
EG0024 events4 affected64 at risk
EG003
LARGE INTESTINE POLYP
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0013 events2 affected21 at risk
EG0024 events3 affected64 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00032 events24 affected43 at risk
EG0019 events6 affected21 at risk
EG00241 events30 affected64 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0010 events0 affected21 at risk
EG0024 events4 affected64 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00018 events10 affected43 at risk
EG0019 events3 affected21 at risk
EG00227 events13 affected64 at risk
EG003
CHILLS
General disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0014 events3 affected21 at risk
EG0028 events7 affected64 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG00028 events20 affected43 at risk
EG0019 events7 affected21 at risk
EG00237 events27 affected64 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected43 at risk
EG0013 events3 affected21 at risk
EG0025 events4 affected64 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected64 at risk
EG003
OEDEMA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected64 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected43 at risk
EG0018 events6 affected21 at risk
EG00216 events14 affected64 at risk
EG003
PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0013 events3 affected21 at risk
EG0024 events4 affected64 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected43 at risk
EG0013 events3 affected21 at risk
EG0029 events8 affected64 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected64 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0011 events1 affected21 at risk
EG0023 events3 affected64 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0014 events3 affected21 at risk
EG0026 events5 affected64 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0013 events2 affected21 at risk
EG0024 events3 affected64 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0014 events3 affected21 at risk
EG0029 events8 affected64 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0011 events1 affected21 at risk
EG0026 events6 affected64 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0013 events3 affected21 at risk
EG0027 events7 affected64 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0011 events1 affected21 at risk
EG0023 events3 affected64 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG00029 events15 affected43 at risk
EG00115 events9 affected21 at risk
EG00244 events24 affected64 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0005 events2 affected43 at risk
EG0018 events2 affected21 at risk
EG00213 events4 affected64 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG00011 events10 affected43 at risk
EG0012 events2 affected21 at risk
EG00213 events12 affected64 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
SKIN ABRASION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0012 events2 affected21 at risk
EG0024 events4 affected64 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0008 events6 affected43 at risk
EG0017 events2 affected21 at risk
EG00215 events8 affected64 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00013 events10 affected43 at risk
EG0013 events2 affected21 at risk
EG00216 events12 affected64 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0014 events2 affected21 at risk
EG0028 events6 affected64 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0013 events3 affected21 at risk
EG0027 events7 affected64 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected64 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected43 at risk
EG0013 events2 affected21 at risk
EG0026 events4 affected64 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00028 events12 affected43 at risk
EG0012 events2 affected21 at risk
EG00230 events14 affected64 at risk
EG003
LYMPHOCYTE COUNT INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00010 events6 affected43 at risk
EG0010 events0 affected21 at risk
EG00210 events6 affected64 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00060 events20 affected43 at risk
EG0011 events1 affected21 at risk
EG00261 events21 affected64 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00035 events19 affected43 at risk
EG0011 events1 affected21 at risk
EG00236 events20 affected64 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0006 events4 affected43 at risk
EG0011 events1 affected21 at risk
EG0027 events5 affected64 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected21 at risk
EG0024 events4 affected64 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00040 events18 affected43 at risk
EG0016 events2 affected21 at risk
EG00246 events20 affected64 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0013 events3 affected21 at risk
EG0028 events8 affected64 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected43 at risk
EG0012 events2 affected21 at risk
EG0028 events7 affected64 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0018 events3 affected21 at risk
EG00212 events6 affected64 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0009 events7 affected43 at risk
EG0012 events1 affected21 at risk
EG00211 events8 affected64 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected64 at risk
EG003
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0009 events7 affected43 at risk
EG0018 events6 affected21 at risk
EG00217 events13 affected64 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00022 events10 affected43 at risk
EG0017 events4 affected21 at risk
EG00229 events14 affected64 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00010 events6 affected43 at risk
EG0013 events1 affected21 at risk
EG00213 events7 affected64 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00017 events9 affected43 at risk
EG0016 events3 affected21 at risk
EG00223 events12 affected64 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00015 events11 affected43 at risk
EG00111 events5 affected21 at risk
EG00226 events16 affected64 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00017 events10 affected43 at risk
EG0011 events1 affected21 at risk
EG00218 events11 affected64 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00016 events12 affected43 at risk
EG0013 events2 affected21 at risk
EG00219 events14 affected64 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00010 events6 affected43 at risk
EG0013 events3 affected21 at risk
EG00213 events9 affected64 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0007 events5 affected43 at risk
EG0013 events3 affected21 at risk
EG00210 events8 affected64 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0024 events3 affected64 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected43 at risk
EG0014 events4 affected21 at risk
EG00212 events12 affected64 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0024 events3 affected64 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0015 events5 affected21 at risk
EG00210 events10 affected64 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0014 events1 affected21 at risk
EG0028 events5 affected64 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected43 at risk
EG0015 events4 affected21 at risk
EG00211 events10 affected64 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0012 events2 affected21 at risk
EG0025 events5 affected64 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0005 events2 affected43 at risk
EG0011 events1 affected21 at risk
EG0026 events3 affected64 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0008 events6 affected43 at risk
EG0011 events1 affected21 at risk
EG0029 events7 affected64 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00014 events12 affected43 at risk
EG0016 events4 affected21 at risk
EG00220 events16 affected64 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0013 events2 affected21 at risk
EG0025 events4 affected64 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected64 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0013 events2 affected21 at risk
EG0024 events3 affected64 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected43 at risk
EG0016 events6 affected21 at risk
EG00211 events9 affected64 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0012 events2 affected21 at risk
EG0026 events6 affected64 at risk
EG003
BLADDER SPASM
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0013 events3 affected21 at risk
EG0025 events5 affected64 at risk
EG003
ERECTILE DYSFUNCTION
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG00018 events14 affected43 at risk
EG0015 events4 affected21 at risk
EG00223 events18 affected64 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG00017 events13 affected43 at risk
EG0013 events3 affected21 at risk
EG00220 events16 affected64 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected43 at risk
EG0010 events0 affected21 at risk
EG0025 events4 affected64 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0007 events6 affected43 at risk
EG0015 events4 affected21 at risk
EG00212 events10 affected64 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected43 at risk
EG0011 events1 affected21 at risk
EG0027 events7 affected64 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0014 events4 affected21 at risk
EG0025 events5 affected64 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0024 events3 affected64 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected43 at risk
EG0012 events2 affected21 at risk
EG0027 events5 affected64 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events2 affected43 at risk
EG0012 events2 affected21 at risk
EG0026 events4 affected64 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected43 at risk
EG0012 events2 affected21 at risk
EG0027 events6 affected64 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0025 events3 affected64 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
HAIR COLOUR CHANGES
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected21 at risk
EG0023 events3 affected64 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected43 at risk
EG0011 events1 affected21 at risk
EG0025 events5 affected64 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected43 at risk
EG0010 events0 affected21 at risk
EG0026 events5 affected64 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected43 at risk
EG0016 events4 affected21 at risk
EG00211 events8 affected64 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected43 at risk
EG00112 events6 affected21 at risk
EG00220 events14 affected64 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected21 at risk
EG0023 events3 affected64 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG00012 events7 affected43 at risk
EG0013 events3 affected21 at risk
EG00215 events10 affected64 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.