Trial Outcomes & Findings for Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01349972)
NCT ID: NCT01349972
Last Updated: 2017-07-31
Results Overview
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
3 years
Results posted on
2017-07-31
Participant Flow
Participant milestones
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
58
|
|
Overall Study
COMPLETED
|
109
|
56
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=114 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=58 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsBone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=109 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=56 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Complete Response Rate
|
76 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Up to 14 days after completion of study treatmentPopulation: Number of evaluable subjects
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=109 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=56 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade
|
156 Number of events
|
77 Number of events
|
SECONDARY outcome
Timeframe: Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 yearsProbabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated. Disease-free survival Overall survival was defined from date of randomization to death or last known follow-up. Event free survival was defined as date of randomization to the first occurrence of persistent AML after 1 cycle of induction, relapse or death. Patients were censored for event free survival if they had received non-protocol therapy or a stem cell transplant.
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=114 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=58 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Disease-free Survival
|
1.46 years
Interval 1.06 to 2.11
|
1.85 years
Interval 1.35 to 3.33
|
SECONDARY outcome
Timeframe: 4 yearsProbabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=109 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=56 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Overall Survival
|
1.46 years
Interval 0.09 to 2.12
|
1.850 years
Interval 1.35 to 3.33
|
SECONDARY outcome
Timeframe: From study start to 14 days after the start of treatmentComparisons of the treatments with respect to MRD will be based on the number of patients with MRD at day 14 after the start of treatment.
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=102 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=55 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Number of Patients With Minimal Residual Disease
|
26 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 4 yearsProbabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.
Outcome measures
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=76 Participants
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=26 Participants
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Progression-free Survival
|
0.81 years
Interval 0.42 to 0.98
|
0.28 years
Interval 0.11 to 1.11
|
Adverse Events
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
Serious events: 53 serious events
Other events: 32 other events
Deaths: 0 deaths
Arm II (Cytarabine, Daunorubicin Hydrochloride)
Serious events: 21 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=114 participants at risk
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=58 participants at risk
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
bone marrow hypocellular
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
1.8%
2/114 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
atrial fibrillation
|
0.88%
1/114 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Cardiac disorders
cardiac chest pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
heart failure
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Cardiac disorders
left ventricular systolic dysfunction
|
4.4%
5/114 • Number of events 5
|
0.00%
0/58
|
|
Cardiac disorders
myocardial infarction
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Cardiac disorders
pericardial effusion
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
pericarditis
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Endocrine disorders
thyrotoxicosis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
ileal perforation
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
peritoneal necrosis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
gastrointestinal hemmorrhage
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
General disorders
death
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
General disorders
fever
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Immune system disorders
cytokine release syndrome
|
2.6%
3/114 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
appendicitis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
lung infection
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Infections and infestations
sepsis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Immune system disorders
sogt tissue infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
blood bilirubin increased
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Investigations
creatinine increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
QTc prolonged
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
alkaline phosphatase increased
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
1.8%
2/114 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
tumor lysis syndrome
|
3.5%
4/114 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
seizure
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
acute kidney injury
|
1.8%
2/114 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Renal and urinary disorders
chronic kidney disease
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
renal insufficiency
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
necrotic bladder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Vascular disorders
thrombotic event
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
adult respiratory distress syndrome
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
capillary leak syndrome
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
hypertension
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
Other adverse events
| Measure |
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)
n=114 participants at risk
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm II (Cytarabine, Daunorubicin Hydrochloride)
n=58 participants at risk
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.
daunorubicin hydrochloride: Given IV
cytarabine: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Febril eNeutropenia
|
4.4%
5/114 • Number of events 5
|
12.1%
7/58 • Number of events 7
|
|
Infections and infestations
Sepsis
|
3.5%
4/114 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Bacteremia
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Infections and infestations
Pneumonia
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Infectious Enterocolitis
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Gastrointestinal disorders
mucositis
|
0.88%
1/114 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.88%
1/114 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Investigations
Hypokalemia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
Mypocardial Infarction
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Investigations
Hypophosphatemia
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Fatigue
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
3/114 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
4/114 • Number of events 4
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.88%
1/114 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Hypocalcemia
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Vascular disorders
Hypotension
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Investigations
GGT increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/114
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.88%
1/114 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Blood bilirubin increased
|
2.6%
3/114 • Number of events 3
|
0.00%
0/58
|
|
General disorders
Multi-organ failure
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Gastrointestinal disorders
Diarrhea
|
3.5%
4/114 • Number of events 4
|
0.00%
0/58
|
|
General disorders
Edema
|
1.8%
2/114 • Number of events 2
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Investigations
INR increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
Sinus Tachycardia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/58
|
Additional Information
Joshua Zeidner
University of North Carolina, Lineberger Comprehensive Cancer Center
Phone: (919) 962-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60