Trial Outcomes & Findings for A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML) (NCT NCT01994837)
NCT ID: NCT01994837
Last Updated: 2018-06-06
Results Overview
The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier
Results posted on
2018-06-06
Participant Flow
All participants who received at least 1 dose of study drug
Participant milestones
| Measure |
ABT-199
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Overall Study
STARTED
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32
|
|
Overall Study
Treated
|
32
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
ABT-199
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Overall Study
Progressive disease per protocol
|
23
|
|
Overall Study
Adv event related to progressive disease
|
3
|
|
Overall Study
Fatal progressive disease
|
2
|
|
Overall Study
Adverse event not related to progression
|
1
|
|
Overall Study
Chose palliative care
|
1
|
|
Overall Study
Proceeded to transplant
|
1
|
|
Overall Study
Removed from study due to no response
|
1
|
Baseline Characteristics
A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Age, Continuous
|
65.9 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
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16 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Objective Remission Rate
|
18.8 percentage of participants
Interval 7.2 to 36.4
|
SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Complete Remission Rate
|
6.3 percentage of participants
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SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: The duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.
Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
|
Time to Progression
|
2.5 months
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Progression-free Survival
|
2.3 months
Interval 1.0 to 2.7
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SECONDARY outcome
Timeframe: Measured up to 2 years after the last subject had enrolled in the study.Population: All participants who received at least 1 dose of study drug
Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Overall Survival
|
4.7 months
Interval 2.3 to 6.0
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SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Percentage of Participants Who Received Subsequent Stem Cell Transplant
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: Participants with available data
The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate.
Outcome measures
| Measure |
ABT-199
n=23 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Rate of Minimal Residual Disease (MRD) Negativity
|
43.5 percentage of participants
Interval 23.2 to 65.5
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SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
|
Complete Remission With Incomplete Marrow Recovery (CRi) Rate
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlierPopulation: All participants who received at least 1 dose of study drug
The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.
Outcome measures
| Measure |
ABT-199
n=32 Participants
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate
|
18.8 percentage of participants
Interval 7.2 to 36.4
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Adverse Events
ABT-199
Serious events: 27 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-199
n=32 participants at risk
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
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|---|---|
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Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
28.1%
9/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
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|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
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|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
MESENTERITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
ASTHENIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
DEATH
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
PYREXIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
BACTERAEMIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
CELLULITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
ENTEROCOCCAL BACTERAEMIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
LEPTOTRICHIA INFECTION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PHARYNGITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PNEUMONIA
|
15.6%
5/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PSEUDOMONAL BACTERAEMIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PSEUDOMONAS INFECTION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
SEPSIS
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
SEPTIC SHOCK
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
SINUSITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
VULVAL CELLULITIS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
25.0%
8/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
POST HERPETIC NEURALGIA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
PRESYNCOPE
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
3.1%
1/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Vascular disorders
HYPOTENSION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
Other adverse events
| Measure |
ABT-199
n=32 participants at risk
Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Ear and labyrinth disorders
EAR PAIN
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
21.9%
7/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
DIARRHOEA
|
53.1%
17/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
NAUSEA
|
59.4%
19/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
STOMATITIS
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Gastrointestinal disorders
VOMITING
|
40.6%
13/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
ASTHENIA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
CHILLS
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
FATIGUE
|
34.4%
11/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
MALAISE
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
OEDEMA PERIPHERAL
|
25.0%
8/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
General disorders
PYREXIA
|
18.8%
6/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
CANDIDA INFECTION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
CONJUNCTIVITIS
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
PNEUMONIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Injury, poisoning and procedural complications
FALL
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Injury, poisoning and procedural complications
LACERATION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
WEIGHT DECREASED
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
WEIGHT INCREASED
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
25.0%
8/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
25.0%
8/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
37.5%
12/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
34.4%
11/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
31.2%
10/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
DIZZINESS
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
DYSGEUSIA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
HEADACHE
|
34.4%
11/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
SYNCOPE
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Nervous system disorders
TREMOR
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Psychiatric disorders
ANXIETY
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Psychiatric disorders
DELIRIUM
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Psychiatric disorders
INSOMNIA
|
15.6%
5/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Renal and urinary disorders
HAEMOGLOBINURIA
|
9.4%
3/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
28.1%
9/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
21.9%
7/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
25.0%
8/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
6.2%
2/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Vascular disorders
HYPERTENSION
|
12.5%
4/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
|
Vascular disorders
HYPOTENSION
|
15.6%
5/32 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 40 weeks.
Serious adverse events occurring after the study-specific informed consent was signed but prior to the first dose of the investigational product were to be collected only if they were considered by the investigator to be causally related to the study required procedures.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER