Trial Outcomes & Findings for 5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (NCT NCT01038635)
NCT ID: NCT01038635
Last Updated: 2017-02-10
Results Overview
DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
94 participants
Primary outcome timeframe
3-8 week cycles, up to 24 weeks
Results posted on
2017-02-10
Participant Flow
Recruitment Period: December 23, 2009 to June 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 94 participants registered, six were ineligible therefore not assigned to groups nor treated.
Participant milestones
| Measure |
5-AZA + LEN 10 mg
Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m\^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
|
5-AZA + LEN 15 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + LEN 20 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + LEN 75 mg for 5 Days
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + LEN 75 mg for 10 Days
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
Phase II: AZA + LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
|
Phase II: AZA+ LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
3
|
4
|
3
|
7
|
20
|
40
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
5
|
15
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
1
|
0
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
5-AZA + LEN 10 mg
Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m\^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
|
5-AZA + LEN 15 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + LEN 20 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + LEN 75 mg for 5 Days
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + LEN 75 mg for 10 Days
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
Phase II: AZA + LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
|
Phase II: AZA+ LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
2
|
Baseline Characteristics
5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
5-AZA + LEN 10 mg
n=5 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
|
5-AZA + LEN 15 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
|
5-AZA + LEN 20 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + LEN 25 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + 50 LEN
n=4 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + LEN 75 mg 5 Days
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + LEN 75 mg for 10 Days
n=7 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
Phase II: 5-AZA + LEN 50 mg
n=20 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
|
Phase II: AZA+ LEN 25 mg
n=40 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
54 years
n=7 Participants
|
66 years
n=5 Participants
|
66 years
n=4 Participants
|
71 years
n=21 Participants
|
64 years
n=10 Participants
|
63 years
n=115 Participants
|
72 years
n=6 Participants
|
66 years
n=6 Participants
|
67 years
n=64 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
40 Participants
n=64 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
48 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
37 Participants
n=6 Participants
|
80 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
36 Participants
n=6 Participants
|
78 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
7 participants
n=115 Participants
|
20 participants
n=6 Participants
|
40 participants
n=6 Participants
|
88 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 3-8 week cycles, up to 24 weeksDLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.
Outcome measures
| Measure |
5-AZA + 5 Days LEN 10 mg
n=5 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
|
5-AZA + 5 Days LEN 15 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + 5 Days LEN 20 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + 5 Days LEN 25 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + 5 Days LEN 50 mg
n=4 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + 5 Days LEN 75 mg
n=3 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + 10 Days LEN 75 mg 75 mg
n=7 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsResponse defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\^9/L or more, platelet count 100 x 10\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\^9/L, without the need for transfusion of Platelets.
Outcome measures
| Measure |
5-AZA + 5 Days LEN 10 mg
n=28 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
|
5-AZA + 5 Days LEN 15 mg
n=60 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + 5 Days LEN 20 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + 5 Days LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + 5 Days LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + 5 Days LEN 75 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + 10 Days LEN 75 mg 75 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia
|
14 percentage of participants
|
45 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsResponse defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10\^9/L or more, platelet count 100 x 10\^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10\^9/L, without the need for transfusion of Platelets.
Outcome measures
| Measure |
5-AZA + 5 Days LEN 10 mg
n=88 Participants
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
|
5-AZA + 5 Days LEN 15 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + 5 Days LEN 20 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + 5 Days LEN 25 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + 5 Days LEN 50 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + 5 Days LEN 75 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + 10 Days LEN 75 mg 75 mg
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Response: Number of Participants With CR or CRi Response
Complete Remission (CR)
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response: Number of Participants With CR or CRi Response
Incomplete Count Recover (CRi)
|
16 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
5-AZA + LEN 10 mg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
5-AZA + LEN 15 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
5-AZA + LEN 20 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
5-AZA + LEN 25 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
5-AZA + LEN 50 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
5-AZA + 5 Days LEN 75 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
5-AZA + 10 Days LEN 75 mg
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase II: AZA + LEN 50 mg
Serious events: 11 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase II: AZA+ LEN 25 mg
Serious events: 21 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-AZA + LEN 10 mg
n=5 participants at risk
Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
|
5-AZA + LEN 15 mg
n=3 participants at risk
Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + LEN 20 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + LEN 25 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + LEN 50 mg
n=4 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + 5 Days LEN 75 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + 10 Days LEN 75 mg
n=7 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
Phase II: AZA + LEN 50 mg
n=20 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
|
Phase II: AZA+ LEN 25 mg
n=40 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
100.0%
3/3 • Number of events 4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
20.0%
4/20 • Number of events 6 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
15.0%
6/40 • Number of events 10 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Altered Mental Status
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
15.0%
3/20 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Branchospasm
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Bruising
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Cardio-pulmonary arrest
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
20.0%
4/20 • Number of events 5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Death
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
42.9%
3/7 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
12.5%
5/40 • Number of events 5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Metabolism and nutrition disorders
Dyhydration
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Investigations
Fever
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Hemorrhage Central Nervous System (CNS)
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Hemorrhage Gastrointestinal
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Infection other
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
100.0%
3/3 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
57.1%
4/7 • Number of events 7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
7.5%
3/40 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Left Pleural Effusion
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
40.0%
2/5 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
35.0%
7/20 • Number of events 8 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
7.5%
3/40 • Number of events 6 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Prolongation of hospitalization
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Injury, poisoning and procedural complications
Right Femur Fracture (fall)
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Right Jaw Swelling
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Seizures
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Subdural Hematoma
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Supraventricular Atrial Flutter
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Syncope
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Thrombus
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
28.6%
2/7 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
Other adverse events
| Measure |
5-AZA + LEN 10 mg
n=5 participants at risk
Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
|
5-AZA + LEN 15 mg
n=3 participants at risk
Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
|
5-AZA + LEN 20 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
|
5-AZA + LEN 25 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
|
5-AZA + LEN 50 mg
n=4 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
|
5-AZA + 5 Days LEN 75 mg
n=3 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
|
5-AZA + 10 Days LEN 75 mg
n=7 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
|
Phase II: AZA + LEN 50 mg
n=20 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
|
Phase II: AZA+ LEN 25 mg
n=40 participants at risk
5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinarty Tract Infection (UTI)
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Scalp Pruritis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Musculoskeletal and connective tissue disorders
Severe muscle spasms of the lower back
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Subdural Hemorrhage
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Syncopal Episode
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Tooth Abcess/Infection
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Unsteady gait
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Vancomycin-resistant enterococci infection (VRE)
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Weakness
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
40.0%
8/20 • Number of events 8 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
27.5%
11/40 • Number of events 11 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right Flank
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Alteration in mental status
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Aspergillus fungal pneumonia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral parotitis
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
C. difficile colitis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Change of smell
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Chest pain unclear etiology
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Psychiatric disorders
Cognitive changes
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
28.6%
2/7 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
20.0%
4/20 • Number of events 4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
40.0%
16/40 • Number of events 16 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Coronary artery disease (caused chest pain)
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Investigations
Creatine Elevation
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
15.0%
6/40 • Number of events 6 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
7.5%
3/40 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Infection, E-coli bacteremia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Investigations
Elevated bilirubin
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Enterococcus bacteremia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
50.0%
2/4 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
42.9%
3/7 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Fever
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
40.0%
16/40 • Number of events 16 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Fluid retention
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Fungal infection/Skin nodules
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Infection, Fungal pneumonia
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
15.0%
3/20 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Gum Hemorrhage
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Gum infection (left jaw cellulitis and gingivitis)
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
influenzae, Haemophilus and stenotrophomonas
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Hand tremors
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Intracranial hemorrhage/bleed
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
1/4 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
17.5%
7/40 • Number of events 7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Jitteriness
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Injury, poisoning and procedural complications
Infection of intravenous line
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
2/40 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Macropapular rash on trunk
|
—
0/0 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
General disorders
Multi organ failure
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
15.0%
3/20 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
17.5%
7/40 • Number of events 7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Nervous system disorders
Night sweats
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Investigations
Non-neutropenic fever
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
66.7%
2/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
nonpruritic skin rash
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Infections and infestations
Pneumonia
|
60.0%
3/5 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
33.3%
1/3 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
28.6%
2/7 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
10/40 • Number of events 10 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Cardiac disorders
possible chemotherapy-related cardiomyopathy
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
7.5%
3/40 • Number of events 3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
50.0%
2/4 • Number of events 2 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
25.0%
10/40 • Number of events 10 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Renal and urinary disorders
Renal failures
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
14.3%
1/7 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/40 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/20 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/4 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/3 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
0.00%
0/7 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
5.0%
1/20 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
2.5%
1/40 • Number of events 1 • Adverse events collected for 28 day cycle, up to 8 weeks following first course.
|
Additional Information
Guillermo Garcia-Manero, MD/Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place