Trial Outcomes & Findings for Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL (NCT NCT03045328)
NCT ID: NCT03045328
Last Updated: 2021-09-29
Results Overview
Complete Response (CR) will be assessed as the number of participants who, based on investigator assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, achieve a complete remission. IWCLL complete remission is defined as follows. * Lymphadenopathy: none \> 1.5 cm * Blood lymphocytes: \< 4,000/µL * Hepatomegaly: none * Splenomegaly: none * Bone marrow: normocellular with \< 30 lymphocytes, no B lymphoid nodules. The outcome is reported as the number of participants who achieve CR, a number without dispersion.
COMPLETED
PHASE2
22 participants
62 weeks
2021-09-29
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib, Venetoclax)
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Ibrutinib, Venetoclax)
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=22 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 62 weeksPopulation: Some participants withdrew consent before the assessment.
Complete Response (CR) will be assessed as the number of participants who, based on investigator assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, achieve a complete remission. IWCLL complete remission is defined as follows. * Lymphadenopathy: none \> 1.5 cm * Blood lymphocytes: \< 4,000/µL * Hepatomegaly: none * Splenomegaly: none * Bone marrow: normocellular with \< 30 lymphocytes, no B lymphoid nodules. The outcome is reported as the number of participants who achieve CR, a number without dispersion.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=20 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Complete Response (CR)
|
12 Participants
|
SECONDARY outcome
Timeframe: 117 weeksPopulation: Some participants withdrew consent before the assessment.
Duration of response (DoR) refers to a participant maintaining clinical response after achieving either complete response (CR) or partial response (PR). The outcome is reported as the number of subjects who have maintained clinical response through 117 weeks. Response defined as the following. CR. * Lymphadenopathy: none \> 1.5 cm * Blood lymphocytes: \< 4,000/µL * Hepatomegaly: none * Splenomegaly: none * Bone marrow: normocellular with \< 30 lymphocytes, no B lymphoid nodules. PR. * Lymphadenopathy: decrease ≥ 50% * Blood lymphocytes: decrease ≥ 50% * Hepatomegaly: decrease ≥ 50% * Splenomegaly: decrease ≥ 50% * Bone marrow: not considered.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=17 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Duration of Response (DoR)
|
15 Participants
|
SECONDARY outcome
Timeframe: 117 weeksPopulation: Test results were not available for all participants. "Negligible" was considered as negative.
Minimal residual disease (MRD) refers to the small numbers of leukemic cells that can remain in the participant after treatment, and may not be associated with any symptoms (remission). Although the participant may feel "healthy," the MRD is a major cause of eventual leukemic relapse. "MRD-negative" is the ideal treatment outcome. MRD negativity was defined as less than one leukemic cell per 10,000 leukocytes as assessed by bone marrow-based flow cytometry. The outcome is reported as the number of participants who were positive for MRD, or negative.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=16 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Minimal Residual Disease (MRD)
Minimal residual disease (MRD)-negative
|
13 Participants
|
|
Minimal Residual Disease (MRD)
Minimal residual disease (MRD)-positive
|
3 Participants
|
SECONDARY outcome
Timeframe: 62 weeksPopulation: Some participants withdrew before the assessment.
Overall response (OR) is the overall number of subjects that begin treatment and achieve a complete response (CR); partial response (PR); or Stable Disease (SD) 62 weeks after the beginning of treatment, according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. IWCLL CR is defined as follows. The outcome is reported as the number of participants who achieve CR, PR, or SD, and number without dispersion. CR: * Lymphadenopathy: none \> 1.5 cm * Blood lymphocytes: \< 4,000/µL * Hepatomegaly: none * Splenomegaly: none * Bone marrow: normocellular with \< 30 lymphocytes, no B lymphoid nodules. PR: * Lymphadenopathy: decrease ≥ 50% * Blood lymphocytes: decrease ≥ 50% * Hepatomegaly: decrease ≥ 50% * Splenomegaly: decrease ≥ 50% * Bone marrow: not considered. SD: * Lymphadenopathy: change of ± 49% * Blood lymphocytes: change of ± 49% * Hepatomegaly: change of ± 49% * Splenomegaly: change of ± 49% * Bone marrow: not considered.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=20 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Overall Response (OR)
Complete Response (CR)
|
12 Participants
|
|
Overall Response (OR)
Partial Response (PR)
|
8 Participants
|
|
Overall Response (OR)
Stable Disease (SD)
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 117 weeksPopulation: Those participants who withdrew consent or were withdrawn for other medical treatments before 117 weeks are not included.
Overall survival (OS) represents the amount of time the participants remain alive after treatment. The outcome is reported as the number of participants remaining alive at 117 weeks (about 2 years and 3 months) after the start of treatment, a number without dispersion.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=16 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Overall Survival (OS)
|
16 Participants
|
SECONDARY outcome
Timeframe: 117 weeksPopulation: Some participants withdrew consent before the assessment.
Progression-free survival (PFS) is a term that means to remain alive with progressive disease (PD). PD is defined as * Lymphadenopathy: Increase ≥ 50% * Blood lymphocytes: Increase ≥ 50% * Hepatomegaly: Increase ≥ 50% * Splenomegaly: Increase ≥ 50% * Bone marrow: not considered. The outcome is reported as the number of participants who remained alive without PD 117 weeks after the beginning of treatment.
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=17 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Progression-free Survival (PFS)
|
15 Participants
|
SECONDARY outcome
Timeframe: Through 117 weeksPopulation: An insufficient number of participants have experienced disease progression to determine a median value for that time period. This is expressed statistically as "Median Not Reached."
Time-to-progression (TTP) is a measure of the length of time from the beginning of treatment until progressive disease (PD). PD is defined as * Lymphadenopathy: Increase ≥ 50% * Blood lymphocytes: Increase ≥ 50% * Hepatomegaly: Increase ≥ 50% * Splenomegaly: Increase ≥ 50% * Bone marrow: not considered. The outcome will be reported as the median TTP as determined by Kaplan-Meier methodology, with 95% confidence interval (95% CI).
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=17 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Time-to-progression (TTP)
|
NA months
An insufficient number of participants have experienced disease progression to determine a median value for that time period. This is expressed statistically as "Median Not Reached."
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 117 weeksPopulation: An insufficient number of participants have advanced to a next treatment to determine a median value for that time period. This is expressed statistically as "Median Not Reached."
The time-to-next-treatment (TTNT) is a measure of the period of time from the beginning of treatment until the patient has to receive a different treatment for his/her disease. TTNT was assessed as the time period until the participants next anti-chronic lymphocytic leukemia (CLL) treatment. The outcome will be reported as the median TTNT as determined by Kaplan-Meier methodology, with 95% confidence interval (95% CI).
Outcome measures
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=17 Participants
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Time-to-next-treatment (TTNT)
|
NA months
An insufficient number of participants have advanced to a next treatment to determine a median value for that time period. This is expressed statistically as "Median Not Reached."
|
Adverse Events
Treatment (Ibrutinib, Venetoclax)
Serious adverse events
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=22 participants at risk
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Ear and labyrinth disorders
Mastoiditis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Injury, poisoning and procedural complications
Fracture Skull
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Vascular disorders
Hematoma
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Infections and infestations
Sepsis
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other Hodgkins Lymphoma
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other Squamous cell Carcinoma
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Acute heart failure
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Aortic valve disease; Critical Stenosis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Prostatectomy Pros
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
Other adverse events
| Measure |
Treatment (Ibrutinib, Venetoclax)
n=22 participants at risk
Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
Venetoclax: Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
|
|---|---|
|
Investigations
Neutrophil count decreased
|
86.4%
19/22 • Number of events 47 • 117 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
81.8%
18/22 • Number of events 45 • 117 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
59.1%
13/22 • Number of events 16 • 117 weeks
|
|
Investigations
Lymphocyte count decreased
|
36.4%
8/22 • Number of events 8 • 117 weeks
|
|
Investigations
Investigations - Other, Absolute monocyte
|
13.6%
3/22 • Number of events 6 • 117 weeks
|
|
Investigations
Investigations - Other, Phosphorous level elevated
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Others, Tympanomastoidectomy
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Eye disorders
Eye disorders-Other, Bilateral optic neuropathy
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Eye disorders
Glaucoma
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Eye disorders
Eye disorders-Other, cataracts, bilateral surgery
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
77.3%
17/22 • Number of events 26 • 117 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
11/22 • Number of events 14 • 117 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
31.8%
7/22 • Number of events 8 • 117 weeks
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Number of events 4 • 117 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
18.2%
4/22 • Number of events 4 • 117 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders-others, upper gastrointestinal bleeding
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders-others, Oral stomatitis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Gastrointestinal disorders
Fatigue
|
45.5%
10/22 • Number of events 12 • 117 weeks
|
|
Gastrointestinal disorders
Fever
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Infections and infestations
Upper respiratory infection
|
40.9%
9/22 • Number of events 11 • 117 weeks
|
|
Infections and infestations
Sinusitis
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Infections and infestations
Sepsis
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Infections and infestations
Infections and Infestations, other, HSV
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Investigations
White blood cell decreased
|
90.9%
20/22 • Number of events 41 • 117 weeks
|
|
Investigations
Platelet count decreased
|
81.8%
18/22 • Number of events 33 • 117 weeks
|
|
Investigations
Creatinine increased
|
27.3%
6/22 • Number of events 7 • 117 weeks
|
|
Investigations
Investigations. Other Lactate dehydrogenase increase
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
45.5%
10/22 • Number of events 18 • 117 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.8%
7/22 • Number of events 18 • 117 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
40.9%
9/22 • Number of events 9 • 117 weeks
|
|
Investigations
Blood bilirubin increased
|
13.6%
3/22 • Number of events 5 • 117 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition disorders-Others. Hypogammaglobulinemia
|
22.7%
5/22 • Number of events 9 • 117 weeks
|
|
General disorders
Edema limbs
|
36.4%
8/22 • Number of events 8 • 117 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
18.2%
4/22 • Number of events 4 • 117 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
3/22 • Number of events 4 • 117 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Nervous system disorders
Peripheral Neuropathy
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders, Other, Varicose veins
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Others prostate cancer
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Renal and urinary disorders
Acute kidney Injury
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.7%
5/22 • Number of events 5 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.6%
3/22 • Number of events 3 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Vascular disorders
Hypertension
|
22.7%
5/22 • Number of events 8 • 117 weeks
|
|
Vascular disorders
Chest pain
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Heart failure
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Cardiac disorders-Other, ablation
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Bradycardia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
59.1%
13/22 • Number of events 13 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
22.7%
5/22 • Number of events 6 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.7%
5/22 • Number of events 6 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
18.2%
4/22 • Number of events 4 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders-Other, Cellulitis
|
9.1%
2/22 • Number of events 2 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Nervous system disorders
Paresthesia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Others, Lentigo melanoma
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders-Other, subcutaneous tissue disorder
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders-Other, Rosacea
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders-Other, Eczema
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Infections and infestations
Paronychia
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
|
Cardiac disorders
Aortic valve disease; Critical Stenosis
|
4.5%
1/22 • Number of events 1 • 117 weeks
|
Additional Information
Steven Edward Coutre, Professor of Medicine (Hematology)
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place