Trial Outcomes & Findings for Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage (NCT NCT00905034)
NCT ID: NCT00905034
Last Updated: 2015-06-29
Results Overview
Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
6 cycles (cycle = 28 days)
Results posted on
2015-06-29
Participant Flow
Recruitment Period: March 6, 2009 to May 6, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
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|---|---|
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Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Baseline characteristics by cohort
| Measure |
MOAD
n=37 Participants
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
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|---|---|
|
Age, Continuous
|
42 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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37 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 cycles (cycle = 28 days)Population: Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.
Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
Outcome measures
| Measure |
MOAD
n=36 Participants
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
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|---|---|
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Complete Response (CR) Rate
|
28 percentage of participants
|
Adverse Events
MOAD
Serious events: 33 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOAD
n=37 participants at risk
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
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|---|---|
|
Cardiac disorders
Cardiopulmonary Arrest
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Hypotension
|
10.8%
4/37 • Number of events 5 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dehydration
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mucositis
|
10.8%
4/37 • Number of events 4 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Abdominal Pain
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Death
|
37.8%
14/37 • Number of events 14 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Weakness
|
8.1%
3/37 • Number of events 3 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic Abcess
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver Failure
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteremia
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candida Gabrata Infection
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Colitis
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection due to Catheter
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Neutropenic Fever
|
18.9%
7/37 • Number of events 8 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pancreatitis
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Parotiditis
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
24.3%
9/37 • Number of events 9 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic Shock
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septicemia
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Elevated Alanine transaminase
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Right Hip Fracture/Fall
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Altered Mental Status
|
5.4%
2/37 • Number of events 2 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paralysis due to CNS disease
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Leptomeningeal disease
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Pulmonary Embolism
|
2.7%
1/37 • Number of events 1 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
MOAD
n=37 participants at risk
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m\^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m\^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m\^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 \& 15-18; Rituximab 375 mg/m\^2 IV days 1 \& 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
|
|---|---|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
91.9%
34/37 • Number of events 34 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Elevated bilirubin
|
83.8%
31/37 • Number of events 31 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Decreased fibrinogen
|
70.3%
26/37 • Number of events 26 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
29.7%
11/37 • Number of events 11 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy
|
27.0%
10/37 • Number of events 10 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Elevated amylase/lipase
|
24.3%
9/37 • Number of events 9 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mucositis
|
21.6%
8/37 • Number of events 8 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.6%
8/37 • Number of events 8 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
18.9%
7/37 • Number of events 7 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombosis
|
13.5%
5/37 • Number of events 5 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
4/37 • Number of events 4 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.8%
4/37 • Number of events 4 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
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70.3%
26/37 • Number of events 40 • Adverse events collected through 28 day cycle, up to six cycles. Overall collection period: April 2009 to February 2013.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Additional Information
Gautam Borthakur, MD/Associate Professor, Leukemia
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-563-1586
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place