Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy (NCT NCT00509093)
NCT ID: NCT00509093
Last Updated: 2020-03-17
Results Overview
PFS measured from the date of Complete Response (CR) to the date of relapse or death. Progression defined as any of the following event: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management This outcome will be reported as median progression-free survival in months for participants less than 60 years of age.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
up to 5 years from the End of Treatment
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Transformed into MDS
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate
n=32 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Age, Customized
20-29 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 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
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 years from the End of TreatmentPopulation: All participants less than 60 years of age
PFS measured from the date of Complete Response (CR) to the date of relapse or death. Progression defined as any of the following event: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management This outcome will be reported as median progression-free survival in months for participants less than 60 years of age.
Outcome measures
| Measure |
Imatinib Mesylate
n=21 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age
|
52.1 months
Interval 9.3 to
Not enough events to estimate upper limit of 95% confidence interval
|
PRIMARY outcome
Timeframe: up to 5 years from the End of TreatmentPopulation: All participants 60 years or older.
Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death.
Outcome measures
| Measure |
Imatinib Mesylate
n=11 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Progression-free Survival for Patients 60 Years of Age and Older
|
10.7 months
Interval 1.7 to 20.8
|
PRIMARY outcome
Timeframe: at 8 and 13 months after treatment.Population: All participants less than 60 years of age
Percent of participants less than 60 years of age with PFS at 8 and 13 months post-treatment
Outcome measures
| Measure |
Imatinib Mesylate
n=21 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment
at 8 months post treatment
|
76.2 percent of participants
|
|
Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment
at 13 months post treatment
|
54.5 percent of participants
|
PRIMARY outcome
Timeframe: at 8 and 13 months after treatment.Population: All participants 60 years or older
Percent of participants 60 years of age or older with PFS at 8 and 13 months post-treatment
Outcome measures
| Measure |
Imatinib Mesylate
n=11 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment
at 8 months post treatment
|
61.9 percent of participants
|
|
Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment
at 13 months post treatment
|
36.4 percent of participants
|
SECONDARY outcome
Timeframe: 13 months from start of treatmentPopulation: Number of patients (%) experiencing the adverse event
Number of patients (%) experiencing an adverse event See adverse events section for details
Outcome measures
| Measure |
Imatinib Mesylate
n=32 Participants
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Toxicity as Measured by NCI CTC v. 3.0
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Imatinib Mesylate
Serious events: 5 serious events
Other events: 30 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Imatinib Mesylate
n=32 participants at risk
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Cardiac disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
3.1%
1/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Bone
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Cardiac/heart
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Joint
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
Other adverse events
| Measure |
Imatinib Mesylate
n=32 participants at risk
Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period.
Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.
Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.
PCR: AF1q gene analysis (on bone marrow aspirate)
Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a
|
|---|---|
|
Ear and labyrinth disorders
Fullness in Right Ear
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
37.5%
12/32 • Number of events 35 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
43.8%
14/32 • Number of events 41 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.8%
6/32 • Number of events 47 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
43.8%
14/32 • Number of events 30 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Platelets
|
56.2%
18/32 • Number of events 53 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
3.1%
1/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Cardiac disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
aches at base of skull
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
aural stuffiness
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
body aches and chills
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Decreased total protein in blood
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Dyspnea
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
edema in extremities
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
emesis
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
episode of flu
|
3.1%
1/32 • Number of events 11 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
facial edema
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
facial itching
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
hand stiffness
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Edema to face and legs
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Insomnia
|
15.6%
5/32 • Number of events 5 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
intermittent rash
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
loose stool
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
lower extremity edema
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
mild edema in general and particularly in eye area
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
mild swelling/edema
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
mild tingling and discomfort rt lower extremity
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
muscle cramping
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
nasal congestion
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
nausea
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
occasional mild sore throat
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
periorbital edema
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
peri-orbital itchiness
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Periorbital swelling
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
post nasal discharge
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
post-herpetic neuralgia
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
puffiness of eyes
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
right heel pain
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
right shoulder discomfort
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
sore throat
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
soreness in left ear
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
stiff neck
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
stomach burning
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
upper back discomfort
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
upper respiratory infection
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.6%
13/32 • Number of events 17 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Sweating (diaphoresis)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Weight gain
|
18.8%
6/32 • Number of events 6 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
General disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
blisters on feet
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
discoloration of face
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
18.8%
6/32 • Number of events 8 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
9.4%
3/32 • Number of events 5 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Anorexia
|
6.2%
2/32 • Number of events 3 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Skin and subcutaneous tissue disorders
Constipation
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.6%
13/32 • Number of events 20 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Upset Stomach
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
gastroenteritis
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
9.4%
3/32 • Number of events 3 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Nausea
|
53.1%
17/32 • Number of events 30 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
7/32 • Number of events 8 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Hemorrhage, GU - Urinary NOS
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Gastrointestinal disorders
Infected cyst in left groin area; draining pus
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Renal and urinary disorders
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva
|
3.1%
1/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Edema: head and neck
|
25.0%
8/32 • Number of events 9 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Infections and infestations
Edema: limb
|
37.5%
12/32 • Number of events 12 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Edema: viscera
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
"Clear Liquid" coming from left ear
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Small Preauricular Left Node
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Albumin, serum-low (hypoalbuminemia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Blood and lymphatic system disorders
Alkaline phosphatase
|
12.5%
4/32 • Number of events 5 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
12.5%
4/32 • Number of events 7 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
15.6%
5/32 • Number of events 7 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.2%
2/32 • Number of events 3 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
9.4%
3/32 • Number of events 5 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Creatinine
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
12.5%
4/32 • Number of events 6 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
9.4%
3/32 • Number of events 4 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Investigations
Dizziness
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Neuropathy: sensory
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Syncope (fainting)
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Mood alteration - Anxiety
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Mood alteration - Depression
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Psychiatric disorders
Eye Swelling and Redness
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Psychiatric disorders
occasional burning of eyes
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Eye disorders
Optic disc edema
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Eye disorders
Vision-blurred vision
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Eye disorders
Pain - Abdomen NOS
|
12.5%
4/32 • Number of events 5 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Eye disorders
Pain - Back
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Bone
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - External ear
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Extremity-limb
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Head/headache
|
9.4%
3/32 • Number of events 3 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Joint
|
9.4%
3/32 • Number of events 3 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Muscle
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Mild Generalized Body Aches
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
rt ankle pain
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
chronic hip pain
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
lower extremity pain
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
mild cramping
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
sciatica
|
3.1%
1/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Pain NOS
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Stomach
|
6.2%
2/32 • Number of events 6 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Pain - Throat/pharynx/larynx
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Bronchospasm, wheezing
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Nervous system disorders
Cough
|
6.2%
2/32 • Number of events 2 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.4%
3/32 • Number of events 4 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Renal and urinary disorders
Increased Bladder Pressure
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
|
Reproductive system and breast disorders
No Menstrual
|
3.1%
1/32 • Number of events 1 • Up to four weeks after off-study date, an average of 2.6 years
|
Additional Information
Anjali Advani
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: +1 216-445-9354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place