Trial Outcomes & Findings for Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01846624)
NCT ID: NCT01846624
Last Updated: 2018-09-27
Results Overview
The complete remission (CR) rate, or complete response rate, is reported as the sum and proportion of participants that achieved CR or CR with incomplete blood count recovery (CRi), within 12 months of starting midostaurin treatment. * Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions. * CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL. * Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2018-09-27
Participant Flow
Participant milestones
| Measure |
Decitabine, Then Midostaurin
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Decitabine, Then Midostaurin
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Overall Study
Died during induction, no midostaurin
|
1
|
Baseline Characteristics
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Decitabine, Then Midostaurin
n=13 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Only participants that started midostaurin therapy are included in the complete response assessment.
The complete remission (CR) rate, or complete response rate, is reported as the sum and proportion of participants that achieved CR or CR with incomplete blood count recovery (CRi), within 12 months of starting midostaurin treatment. * Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions. * CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL. * Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
| Measure |
Decitabine, Then Midostaurin
n=12 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Complete Remission (CR) Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Only participants that started midostaurin therapy are included in the response assessment.
Overall response rate (ORR) was assessed as the number and proportion of participants who received midostaurin and achieved a partial response (PR), complete response (CR), or complete response with incomplete blood count recovery (CRi). * Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions. * CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL. * Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
| Measure |
Decitabine, Then Midostaurin
n=12 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Overall Response Rate (ORR)
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Does not include participants who did not achieve a documented clinical response. Participants who withdrew to receive hematopoietic cell transplant (HCT) are censored at the last assessment of response prior to HCT.
Response was assessed by evaluations conducted every 3 cycles (12 weeks). Once documented as partial response (PR), complete response (CR), or complete response with incomplete blood count recover (CRi), response status was confirmed every 12 weeks. In responding participants, duration of response was assessed from the start of treatment through the last documented response before documented progressive disease or death. The outcome is reported as the median value for duration of response, with full range. * CR: Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; ANC \> 1000/μL; platelet \> 100,000/μL; independence of red cell transfusions. * CRi: All CR criteria except ANC \< 1000/μL or platelet count \< 100,000/μL. * PR: All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; \& decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
| Measure |
Decitabine, Then Midostaurin
n=10 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Median Duration of Response (DoR)
|
24 weeks
Interval 12.0 to 36.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only participants that started midostaurin therapy, and did not withdraw for hematopoietic cell transplantation, are included in the progression-free survival assessment.
Progression-free survival (PFS) is reported as the number and proportion of participants who did not receive hematopoietic cell transplantation, and who did not experience disease progression or death for any reason within 2 years after starting midostaurin treatment. Progressive disease: Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
Outcome measures
| Measure |
Decitabine, Then Midostaurin
n=9 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Progression-free Survival (PFS)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only participants that started midostaurin therapy are included in the overall survival assessment.
Survival is reported as the number and proportion of participants that received midostaurin who remained alive 2 years after starting midostaurin treatment.
Outcome measures
| Measure |
Decitabine, Then Midostaurin
n=12 Participants
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Overall Survival (OS)
|
2 Participants
|
Adverse Events
Decitabine, Then Midostaurin
Serious events: 13 serious events
Other events: 13 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Decitabine, Then Midostaurin
n=13 participants at risk
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Renal failure
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Hematoma, subdural
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Unresponsive
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
Pain, eye
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Kidney stones (nephrolithiasis)
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Swelling in arms and legs (peripheral edema)
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Bowel obstruction
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Bleeding (hemmorhage)
|
7.7%
1/13 • Number of events 1
|
|
Immune system disorders
Neutropenic fever
|
100.0%
13/13 • Number of events 24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor progression
|
53.8%
7/13 • Number of events 7
|
|
Infections and infestations
Herpetic stomatitis
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Anoxic brain injury
|
23.1%
3/13 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath (dyspnea)
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen in blood (hypoxemia)
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen in tissues (hypoxia)
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Excess fluid around the lungs (pleural effusion)
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection (pneumonia)
|
38.5%
5/13 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
30.8%
4/13 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Decitabine, Then Midostaurin
n=13 participants at risk
INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.
POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
Decitabine: Given IV
Midostaurin: Given PO
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
38.5%
5/13 • Number of events 5
|
|
Cardiac disorders
Hypertension
|
15.4%
2/13 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Hearing loss
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Altered mental status
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Confusion
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Agitation
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Delirium
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Lighted-headed
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Tinnitus
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Vertigo
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Sleep disorders
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Anxiety
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Distress
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Memory loss
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3
|
|
Gastrointestinal disorders
Taste alteration
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal / epigastric discomfort
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Cough
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain with bloating
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Poor appetite
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Metallic taste
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Stomatitis
|
30.8%
4/13 • Number of events 4
|
|
Infections and infestations
Cellulitis
|
23.1%
3/13 • Number of events 3
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Limb edema
|
38.5%
5/13 • Number of events 5
|
|
General disorders
Weight loss
|
30.8%
4/13 • Number of events 4
|
|
General disorders
Alopecia
|
23.1%
3/13 • Number of events 3
|
|
General disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 7
|
|
General disorders
Mouth sores
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Fall
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fracture
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Tingling and weakness
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Foot drop
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Blood-tinged sputum
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain on right thumb
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Shoulder pain
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Facial flushing
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Multi-organ dysfunction
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Leg pain
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Worsening of neuropathy
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain on left side of tongue
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Neck pain
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.5%
5/13 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
23.1%
3/13 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Desquamation on extremities
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Lip lesions
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Lesion in buccal mucosa
|
23.1%
3/13 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Diaphoretic
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
30.8%
4/13 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Viral illness
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Decreased lung breathing sounds
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Invasive lung infection
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
30.8%
4/13 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoptysis
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
38.5%
5/13 • Number of events 5
|
|
Blood and lymphatic system disorders
Chills
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Disease Progression
|
30.8%
4/13 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Increased transfusions
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Macrocytosis
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Cytopenia
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion reaction to platelets
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Restless legs
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Acute renal failure
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase elevated
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Alanine aminotransferase elevated
|
7.7%
1/13 • Number of events 1
|
Additional Information
David Joseph Iberri, MD; Clinical Assistant Professor (Hematology)
Stanford University Medical Center
Phone: 650-498-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place