Trial Outcomes & Findings for Ibrutinib + Venetoclax in Untreated WM (NCT NCT04273139)
NCT ID: NCT04273139
Last Updated: 2026-05-11
Results Overview
Proportion of patients with VGPR to therapy within 24 cycles of therapy initiation. (VGPR is \>90% reduction in serum IgM from baseline)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy.
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Ibrutinib and Venetoclax
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib + Venetoclax in Untreated WM
Baseline characteristics by cohort
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=44 Participants
|
|
Age, Continuous
|
67 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy.Proportion of patients with VGPR to therapy within 24 cycles of therapy initiation. (VGPR is \>90% reduction in serum IgM from baseline)
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy
|
19 Participants
|
SECONDARY outcome
Timeframe: 6 Cycles (28 day cycle)Proportion of patients with a complete response after 6 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Number of Participants With Complete Response (CR) After 6 Cycles
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 Cycles (28 day cycle)Proportion of patients with a complete response after 12 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Number of Participants With Complete Response (CR) After 12 Cycles
|
0 Participants
|
SECONDARY outcome
Timeframe: Complete response to therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy.Proportion of patients with a complete response after 24 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Number of Participants With Complete Response (CR) After 24 Cycles
|
0 Participants
|
SECONDARY outcome
Timeframe: 72 monthsProportion of patients with minor response (MR) , partial response (PR), very good partial response (VGPR), or complete response (CR) to therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 MonthsProportion of patients with a VGPR at 30 months from beginning therapy.
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Rate of VGPR at 30 Months
|
9 Participants
|
SECONDARY outcome
Timeframe: 24 monthsTime from treatment initiation until achievement of a minor response (reduction in serum IgM \>25%) or better.
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Median Time to Response
|
0.9 months
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: 24 monthsTime from treatment initiation until partial response or better (\>50% reduction in serum IgM)
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Median Time to Major Response
|
1.8 months
Interval 1.4 to 1.9
|
SECONDARY outcome
Timeframe: 24 monthsTime from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase).
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Progression Free Survival (PFS) at 24 Months
|
34 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsTime from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase).
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Progression Free Survival (PFS) at 36 Months
|
21 Participants
|
SECONDARY outcome
Timeframe: 48 MonthsTime from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 monthsTime from initiation of IVEN protocol therapy until initiation of new line of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsCTCAE version 5.0
Outcome measures
| Measure |
Ibrutinib and Venetoclax
n=45 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed (CTCAE) Version 5.0
|
45 Participants
|
Adverse Events
Ibrutinib and Venetoclax
Serious events: 10 serious events
Other events: 45 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ibrutinib and Venetoclax
n=45 participants at risk
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Aspiration pneumonia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Laboratory Tumor Lysis Syndrome
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Cardiac disorders
Ventricular tachycardia
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Cardiac disorders
Cardiac arrest
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Vascular disorders
Hematoma
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
Other adverse events
| Measure |
Ibrutinib and Venetoclax
n=45 participants at risk
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Ibrutinib will be administered at a predetermined dose, once daily for 28 days
* TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment)
* Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2.
IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.8%
8/45 • Number of events 8 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Blood and lymphatic system disorders
Easy bleeding
|
13.3%
6/45 • Number of events 6 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Blood and lymphatic system disorders
Petechia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Cardiac disorders
Chest pain
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Cardiac disorders
Palpitations
|
20.0%
9/45 • Number of events 9 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Eye disorders
Blurred vision
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Eye disorders
Dry eye
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Eye disorders
Eye pain
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Eye disorders
Floaters
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Eye disorders
Retinal vein occlusion
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Bloating
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Constipation
|
17.8%
8/45 • Number of events 8 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Diarrhea
|
57.8%
26/45 • Number of events 26 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Dry mouth
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
C. difficile infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Flatulence
|
15.6%
7/45 • Number of events 7 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
GERD
|
28.9%
13/45 • Number of events 13 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Increased appetite
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Mucositis oral
|
35.6%
16/45 • Number of events 16 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Nausea
|
44.4%
20/45 • Number of events 20 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Edema limbs
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Fatigue
|
26.7%
12/45 • Number of events 12 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Increased sensitivity to cold
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Generalized edema
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
General disorders
Malaise
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Folliculitis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Gum infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Herpes simplex reactivation
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
COVID-19 infection
|
11.1%
5/45 • Number of events 5 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Nail infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Papulopustular rash
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Shingles
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Sinusitis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Skin infection
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Soft tissue infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Upper respiratory infection
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Infections and infestations
Urinary tract infection
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Bruising
|
35.6%
16/45 • Number of events 16 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Fall
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
ALT elevation
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
AST elevation
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
LDH increased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Cardiac troponin t increased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Neutrophil count decreased
|
35.6%
16/45 • Number of events 16 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Platelet count decreased
|
13.3%
6/45 • Number of events 6 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Weight gain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Investigations
Weight loss
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
5/45 • Number of events 5 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
15.6%
7/45 • Number of events 7 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Metabolism and nutrition disorders
Laboratory Tumor Lysis Syndrome
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.4%
11/45 • Number of events 11 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
6/45 • Number of events 6 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Stiff joints
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
15.6%
7/45 • Number of events 7 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.6%
7/45 • Number of events 7 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DCIS left breast
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Dizziness
|
22.2%
10/45 • Number of events 10 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Headache
|
13.3%
6/45 • Number of events 6 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Imbalance
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Paresthesia
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Nervous system disorders
Presyncope
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Psychiatric disorders
Hallucinations
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Psychiatric disorders
Insomnia
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Psychiatric disorders
Irritability
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Renal and urinary disorders
Hematuria
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Renal and urinary disorders
Urinary urgency
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Reproductive system and breast disorders
Bleeding
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.8%
8/45 • Number of events 8 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
9/45 • Number of events 9 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Hair thining
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
13.3%
6/45 • Number of events 6 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Fragile skin
|
24.4%
11/45 • Number of events 11 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Lesion
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Nodular rash
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Skin changes
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash not otherwise specified
|
15.6%
7/45 • Number of events 7 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Skin and subcutaneous tissue disorders
skin induration
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Vascular disorders
Hot flashes
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Vascular disorders
Hypertension
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
|
Vascular disorders
Raynaud's symptoms
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place