Trial Outcomes & Findings for A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome (NCT NCT03054896)
NCT ID: NCT03054896
Last Updated: 2026-07-10
Results Overview
The CRR is defined as the proportion of participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) based on 2008 IW-CLL Response Criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Relevant to this endpoint, it is at 3 month.
Results posted on
2026-07-10
Participant Flow
Participant milestones
| Measure |
VR-EPOCH (Cohort 1)
* Standard chemotherapy regimen, DA-EPOCH-R, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400 mg
|
VR-CHOP (Cohort 2)
* Standard chemotherapy regimen, R-CHOP, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400 mg
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
42
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
17
|
Reasons for withdrawal
| Measure |
VR-EPOCH (Cohort 1)
* Standard chemotherapy regimen, DA-EPOCH-R, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400 mg
|
VR-CHOP (Cohort 2)
* Standard chemotherapy regimen, R-CHOP, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400 mg
|
|---|---|---|
|
Overall Study
Death
|
7
|
16
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome
Baseline characteristics by cohort
| Measure |
VR-EPOCH (Cohort 1)
n=27 Participants
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
Venetoclax: Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
|
VR-CHOP (Cohort 2)
n=42 Participants
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
Venetoclax: Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=9 Participants
|
71 years
n=27 Participants
|
60 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
59 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
More Than One Race
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
25 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
63 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Known
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=9 Participants
|
42 participants
n=27 Participants
|
69 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Relevant to this endpoint, it is at 3 month.Population: Only 20 patients started VR-EPOCH (at cycle 2) and were therefore evaluable for this endpoint.
The CRR is defined as the proportion of participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) based on 2008 IW-CLL Response Criteria.
Outcome measures
| Measure |
VR-CHOP (Cohort 2)
n=42 Participants
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
VR-EPOCH (Cohort 1)
n=20 Participants
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
|---|---|---|
|
3-month Rate of Complete Response (CR)
|
0.286 proportion of participants
Interval 0.16 to 0.448
|
0.65 proportion of participants
Interval 0.41 to 0.85
|
SECONDARY outcome
Timeframe: Patients monitored monthly up to the 1 year mark, after that every 3 months, and response assessments every 6 months. After 2 year, monitored every 3 months and response assessments every 12 months. In long- term follow-up every 6 months up to 5 years.Population: No data for patient 54, therefore reporting on 26 instead of 27 patients
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.
Outcome measures
| Measure |
VR-CHOP (Cohort 2)
n=42 Participants
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
VR-EPOCH (Cohort 1)
n=26 Participants
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
|---|---|---|
|
Median Progression-Free Survival (PFS)
|
16.19 months
Interval 5.45 to
Insufficient number of participants with events
|
10.1 months
Interval 3.2 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: No data for patient #54, therefore analyzing 26 instead of 27 patients.
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Outcome measures
| Measure |
VR-CHOP (Cohort 2)
n=42 Participants
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
VR-EPOCH (Cohort 1)
n=26 Participants
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
|---|---|---|
|
Median Overall Survival (OS)
|
NA months
Insufficient number of participants with events
|
19.6 months
Interval 12.0 to
Insufficient number of participants with events
|
Adverse Events
VR-EPOCH (Cohort 1)
Serious events: 19 serious events
Other events: 26 other events
Deaths: 7 deaths
VR-CHOP (Cohort 2)
Serious events: 20 serious events
Other events: 42 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
VR-EPOCH (Cohort 1)
n=27 participants at risk
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
VR-CHOP (Cohort 2)
n=42 participants at risk
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Cardiac arrest
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Enterocolitis
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Rectal pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Death NOS
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Fatigue
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Infusion related reaction
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Lung infection
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Sepsis
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Skin infection
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Upper respiratory infection
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Blood bilirubin increased
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Neutrophil count decreased
|
22.2%
6/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Platelet count decreased
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
White blood cell decreased
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
Other adverse events
| Measure |
VR-EPOCH (Cohort 1)
n=27 participants at risk
* Standard chemotherapy regimen, DA-EPOCH-R
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
VR-CHOP (Cohort 2)
n=42 participants at risk
* Standard chemotherapy regimen, R-CHOP
* Chemotherapy cycles will be administered approximately every 3 weeks
* Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
|
|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Flashing lights
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Floaters
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Glaucoma
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
11.9%
5/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Palpitations
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Sinus tachycardia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
28.6%
12/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Blood and lymphatic system disorders
Anemia
|
63.0%
17/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
69.0%
29/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Blurred vision
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Dry eye
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Eye disorders
Watering eyes
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
6/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Bloating
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Constipation
|
48.1%
13/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
59.5%
25/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Diarrhea
|
37.0%
10/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
59.5%
25/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Dysphagia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Esophagitis
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
25.9%
7/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Ileus
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Mucositis oral
|
22.2%
6/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Nausea
|
51.9%
14/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
59.5%
25/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Chills
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Edema limbs
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
35.7%
15/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Fatigue
|
74.1%
20/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
81.0%
34/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Fever
|
25.9%
7/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Gait disturbance
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Infusion related reaction
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Localized edema
|
14.8%
4/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Malaise
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
General disorders
Pain
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Hepatobiliary disorders
Gallbladder pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Bladder infection
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Lung infection
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Skin infection
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Upper respiratory infection
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Infections and infestations
Wound infection
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Alanine aminotransferase increased
|
29.6%
8/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Alkaline phosphatase increased
|
25.9%
7/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Aspartate aminotransferase increased
|
29.6%
8/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Blood bilirubin increased
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Cholesterol high
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Creatinine increased
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
INR increased
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Investigations - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Lymphocyte count decreased
|
59.3%
16/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
14.3%
6/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Lymphocyte count increased
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Neutrophil count decreased
|
48.1%
13/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
52.4%
22/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Platelet count decreased
|
81.5%
22/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
54.8%
23/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Weight gain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
Weight loss
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Investigations
White blood cell decreased
|
70.4%
19/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
14.3%
6/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.0%
10/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
35.7%
15/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.8%
4/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.7%
11/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.8%
4/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
11.9%
5/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.6%
15/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
14.3%
6/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
70.4%
19/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
28.6%
12/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.7%
11/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
11.9%
5/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
51.9%
14/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
26.2%
11/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
11.9%
5/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.9%
7/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Amnesia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Ataxia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Cognitive disturbance
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Dizziness
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
28.6%
12/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Dysgeusia
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Headache
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
33.3%
14/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Memory impairment
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Paresthesia
|
29.6%
8/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
29.6%
8/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
38.1%
16/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Sinus pain
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Nervous system disorders
Tremor
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Anxiety
|
22.2%
6/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Confusion
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Delirium
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
14.3%
6/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Hallucinations
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Insomnia
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
21.4%
9/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.8%
4/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
14.3%
6/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Hematuria
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Urinary frequency
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Reproductive system and breast disorders
Testicular disorder
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.1%
13/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
19.0%
8/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.0%
10/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
23.8%
10/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.5%
5/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
22.2%
6/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
33.3%
14/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
7.1%
3/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
37.0%
10/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
33.3%
14/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
0.00%
0/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
25.9%
7/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
16.7%
7/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Hematoma
|
3.7%
1/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Hypertension
|
33.3%
9/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
47.6%
20/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Hypotension
|
11.1%
3/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
9.5%
4/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
2.4%
1/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/27 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
4.8%
2/42 • Adverse events (AE) evaluated C1D1-5, D12 and D22 until Venetoclax ramp-up complete, C2 and after at D1 until C13, and then every 3 months through study completion, an average of 5 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place