Trial Outcomes & Findings for LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) (NCT NCT00691938)
NCT ID: NCT00691938
Last Updated: 2016-10-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Completion of Phase I enrollment for MTD (approximately 26 months)
Results posted on
2016-10-13
Participant Flow
The study opened to participant enrollment on 06/23/2008 and closed to participant enrollment on 11/06/2012.
Participant milestones
| Measure |
Level 1
LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 2
LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 3
LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 4
LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5
LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5B
LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Phase II
LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
6
|
8
|
10
|
6
|
14
|
|
Overall Study
COMPLETED
|
4
|
3
|
6
|
8
|
10
|
6
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Level 1
LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 2
LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 3
LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 4
LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5
LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5B
LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Phase II
LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
QTc prolongation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Level 1
n=5 Participants
LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 2
n=3 Participants
LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 3
n=6 Participants
LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 4
n=8 Participants
LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5
n=10 Participants
LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5B
n=6 Participants
LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Phase II
n=14 Participants
LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
68 years
n=5 Participants
|
72 years
n=4 Participants
|
73 years
n=21 Participants
|
71 years
n=8 Participants
|
66 years
n=8 Participants
|
70 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
10 participants
n=21 Participants
|
6 participants
n=8 Participants
|
14 participants
n=8 Participants
|
52 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Completion of Phase I enrollment for MTD (approximately 26 months)Population: After enrolling all Phase I patients in Dose Levels 1-5b, the maximum tolerated dose was not determined. The Phase II portion of the study used the 5b dose level.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=37 Participants
|
|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine
|
40 mg (level 5b dosing schedule)
|
PRIMARY outcome
Timeframe: Up to 12 months* Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL. * Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics. * Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (\< 1,000/μL) or thrombocytopenia (\< 100,000/μL).
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsCytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Rate of Cytogenetic Complete Remission (CRc)
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 months after start of treatmentPopulation: Data was not collected for this outcome measure.
-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Number of participants analyzed are participants that met the criteria for CR or CRi.
Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=6 Participants
|
|---|---|
|
Time to Response
|
91.5 days
Interval 28.0 to 161.0
|
SECONDARY outcome
Timeframe: Up to 13 months after start of treatmentAdverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Fatigue
|
88 percentage of participants
|
|
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Febrile neutropenia
|
76 percentage of participants
|
|
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Diarrhea
|
75 percentage of participants
|
|
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Nausea
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: Completion of follow-up (median follow-up was 58 months)Population: Number of participants analyzed include those participants who met the criteria for CR, CRi, or HI.
Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=7 Participants
|
|---|---|
|
Remission Duration
|
361 days
Interval 172.0 to 490.0
|
SECONDARY outcome
Timeframe: Completion of follow-up (median follow-up was 58 months)Population: Data was not collected for this outcome measure. Progression is very hard to define for MDS and AML and including it as a pre-specified secondary outcome measure in the protocol was an oversight.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of follow-up (median follow-up was 58 months)Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Event-free Survival
|
104 days
Interval 91.3 to 118.0
|
SECONDARY outcome
Timeframe: Completion of follow-up (median follow-up was 58 months)Overall survival is defined as the date of first dose of study drug to the date of death from any cause.
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Overall Survival
|
6.44 months
Interval 0.2 to 63.33
|
SECONDARY outcome
Timeframe: Up to 12 monthsMorphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (\< 1,000/μL) or thrombocytopenia (\< 100,000/μL).
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 months-Hematologic improvement (HI). Includes the following categories: * Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is \< 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks. * Platelet response. Absolute increase of \> 30 x 10\^9/L for patients starting with 20 x 10\^9/L or increase from \< 20 x 10\^9/L to \> 20 x 109/L and by at least 100% * Neutrophil response. At least 100% increase and an absolute increase \> 0.5 x 109/L for patients with pretreatment neutrophils \< 1.0 x 109/L)
Outcome measures
| Measure |
Phase I (Includes Levels 1-5)
n=51 Participants
|
|---|---|
|
Rate of Hematologic Improvement.
|
2.0 percentage of participants
|
Adverse Events
Level 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 4
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Level 5
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Level 5B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Level 1
n=4 participants at risk
LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 2
n=3 participants at risk
LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 3
n=6 participants at risk
LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 4
n=8 participants at risk
LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5
n=10 participants at risk
LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Level 5B
n=6 participants at risk
LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
Phase II
n=14 participants at risk
LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.
Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.
|
|---|---|---|---|---|---|---|---|
|
Investigations
ALT
|
50.0%
2/4
|
66.7%
2/3
|
16.7%
1/6
|
12.5%
1/8
|
10.0%
1/10
|
33.3%
2/6
|
14.3%
2/14
|
|
Investigations
AST
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
33.3%
2/6
|
14.3%
2/14
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Psychiatric disorders
Agitation - mental status change
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
Alkaline phosphatase - high
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
37.5%
3/8
|
10.0%
1/10
|
0.00%
0/6
|
28.6%
4/14
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Immune system disorders
Allergic reaction to transfusion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
General disorders
Angioedema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4
|
66.7%
2/3
|
16.7%
1/6
|
25.0%
2/8
|
50.0%
5/10
|
33.3%
2/6
|
28.6%
4/14
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Arthritic hand pain
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Aspergillus sinusitis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Asthenia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
21.4%
3/14
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
25.0%
2/8
|
10.0%
1/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Atypical fungal lung infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
16.7%
1/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Bilateral hand pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Bilateral lower extremity edema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
4/8
|
50.0%
5/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Surgical and medical procedures
Biopsy site pain
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Eye disorders
Blurred vision
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
33.3%
2/6
|
21.4%
3/14
|
|
Infections and infestations
C. albacans infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
C. neg staph & E. faecalis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
INR
|
50.0%
2/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
C. neg staph & L. buccalis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4
|
33.3%
1/3
|
33.3%
2/6
|
25.0%
2/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Cardiac disorders
Chest pain
|
50.0%
2/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
7.1%
1/14
|
|
Infections and infestations
Citrobacteremia infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
20.0%
2/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Coag neg staphylococcus infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Coag. negative staph infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Coagulase negative staphlococcus infection
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Psychiatric disorders
Confusion
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
30.0%
3/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4
|
33.3%
1/3
|
33.3%
2/6
|
25.0%
2/8
|
50.0%
5/10
|
33.3%
2/6
|
28.6%
4/14
|
|
Investigations
Creatinine
|
50.0%
2/4
|
66.7%
2/3
|
0.00%
0/6
|
25.0%
2/8
|
40.0%
4/10
|
16.7%
1/6
|
14.3%
2/14
|
|
General disorders
Death NOS
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Death due to fall
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
25.0%
2/8
|
10.0%
1/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Psychiatric disorders
Depression
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4
|
33.3%
1/3
|
33.3%
2/6
|
37.5%
3/8
|
70.0%
7/10
|
83.3%
5/6
|
35.7%
5/14
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
General disorders
Dry lips
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4
|
0.00%
0/3
|
16.7%
1/6
|
37.5%
3/8
|
20.0%
2/10
|
33.3%
2/6
|
35.7%
5/14
|
|
Infections and infestations
E. Coli infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Infections and infestations
E. Coli sepsis infection
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
E. Coli urinary tract infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
EBV meningitis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Eccymosis, right arm
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Ecthyma (groin)
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Edema
|
50.0%
2/4
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
General disorders
Edema: limbs
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
14.3%
2/14
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Enterobacter cloacae infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Infections and infestations
Enterococcal line infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
21.4%
3/14
|
|
Infections and infestations
Enterococcus infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Epigastric distress
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
37.5%
3/8
|
0.00%
0/10
|
0.00%
0/6
|
28.6%
4/14
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Eye disorders
Eye itch
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Eye disorders
Eye pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
General disorders
Facial edema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
7.1%
1/14
|
|
General disorders
Fatigue
|
50.0%
2/4
|
66.7%
2/3
|
33.3%
2/6
|
75.0%
6/8
|
60.0%
6/10
|
100.0%
6/6
|
50.0%
7/14
|
|
Infections and infestations
Febrile neutropenia
|
50.0%
2/4
|
33.3%
1/3
|
16.7%
1/6
|
62.5%
5/8
|
70.0%
7/10
|
50.0%
3/6
|
28.6%
4/14
|
|
General disorders
Fever
|
25.0%
1/4
|
33.3%
1/3
|
33.3%
2/6
|
0.00%
0/8
|
20.0%
2/10
|
16.7%
1/6
|
42.9%
6/14
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
Weight gain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Fungal bacteremia/cladosporium infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Fungal pneumonia infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
50.0%
3/6
|
0.00%
0/14
|
|
Infections and infestations
Fungal upper respiratory infection
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
GI bleeding
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
50.0%
3/6
|
14.3%
2/14
|
|
Gastrointestinal disorders
GI upset
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Gait disturbance
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
50.0%
4/8
|
30.0%
3/10
|
66.7%
4/6
|
21.4%
3/14
|
|
General disorders
Generalized pain
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Cardiac disorders
Global hypokinesis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Gram negative sepsis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Gram positive cocci infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
HSV infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
25.0%
1/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
16.7%
1/6
|
28.6%
4/14
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Vascular disorders
Hematoma
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
20.0%
2/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.0%
3/4
|
100.0%
3/3
|
50.0%
3/6
|
37.5%
3/8
|
10.0%
1/10
|
66.7%
4/6
|
50.0%
7/14
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Investigations
Hyperbilirubinemia
|
50.0%
2/4
|
33.3%
1/3
|
33.3%
2/6
|
0.00%
0/8
|
20.0%
2/10
|
0.00%
0/6
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
25.0%
2/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
21.4%
3/14
|
|
Vascular disorders
Hypertension
|
50.0%
2/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4
|
66.7%
2/3
|
50.0%
3/6
|
25.0%
2/8
|
10.0%
1/10
|
33.3%
2/6
|
50.0%
7/14
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
75.0%
3/4
|
66.7%
2/3
|
50.0%
3/6
|
50.0%
4/8
|
50.0%
5/10
|
50.0%
3/6
|
35.7%
5/14
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
2/4
|
66.7%
2/3
|
0.00%
0/6
|
12.5%
1/8
|
30.0%
3/10
|
0.00%
0/6
|
35.7%
5/14
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.0%
3/4
|
66.7%
2/3
|
16.7%
1/6
|
12.5%
1/8
|
60.0%
6/10
|
16.7%
1/6
|
50.0%
7/14
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
2/4
|
33.3%
1/3
|
50.0%
3/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Vascular disorders
Hypotension
|
25.0%
1/4
|
33.3%
1/3
|
16.7%
1/6
|
50.0%
4/8
|
30.0%
3/10
|
0.00%
0/6
|
28.6%
4/14
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
20.0%
2/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Ileal hemorrhage
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Surgical and medical procedures
Incisional pain
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Influenza infection
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
General disorders
Jaw swelling
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Left hip fracture pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Left lower leg joint pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Investigations
Leukocytes
|
75.0%
3/4
|
66.7%
2/3
|
33.3%
2/6
|
75.0%
6/8
|
40.0%
4/10
|
0.00%
0/6
|
64.3%
9/14
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Lung infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
28.6%
4/14
|
|
Investigations
Lymphopenia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
14.3%
2/14
|
|
General disorders
Malaise
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
20.0%
2/10
|
33.3%
2/6
|
21.4%
3/14
|
|
Infections and infestations
Multifocal pneumonia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia (chest)
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Nail changes; dystrophic nails
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4
|
66.7%
2/3
|
33.3%
2/6
|
25.0%
2/8
|
60.0%
6/10
|
66.7%
4/6
|
42.9%
6/14
|
|
Nervous system disorders
Neuropathy - fingers
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Neuropathy - right chest
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Neuropathy - right foot drop
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
Neutrophils
|
25.0%
1/4
|
33.3%
1/3
|
50.0%
3/6
|
62.5%
5/8
|
30.0%
3/10
|
33.3%
2/6
|
35.7%
5/14
|
|
General disorders
Night sweats
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Opportunistic infection NOS
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Oral herpes simplex virus infection
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Oral thrush infection
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
7.1%
1/14
|
|
Investigations
PTT
|
50.0%
2/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
20.0%
2/10
|
16.7%
1/6
|
0.00%
0/14
|
|
General disorders
Pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Parainfluenza infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Penis erythema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Penumonitis, C. glabrata
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Peripheral edema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Perirectal left buttock abscess/ulcer
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
Platelets
|
100.0%
4/4
|
66.7%
2/3
|
50.0%
3/6
|
25.0%
2/8
|
40.0%
4/10
|
100.0%
6/6
|
21.4%
3/14
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Cardiac disorders
Prolonged QTc interval
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged intubation
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
16.7%
1/6
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Pseudomonas bacteremia infection
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Psychiatric disorders
Psychosis - visual hallucinations
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Pulmonary aspergillosis infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodules
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash, actinoform
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash, erythema diffuse
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
33.3%
2/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Rash, macropapular
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Rash, petechiae
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
30.0%
3/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4
|
33.3%
1/3
|
0.00%
0/6
|
25.0%
2/8
|
20.0%
2/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Nervous system disorders
Restless leg syndrome
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Right lower quadrant abdomen ulcer
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
General disorders
Rigors/chills
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
30.0%
3/10
|
16.7%
1/6
|
28.6%
4/14
|
|
Infections and infestations
S. viridians and g+ cocci infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Cardiac disorders
Saccular aneurism
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Eye disorders
Sclera discoloration blue
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Secretions
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Sepsis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
25.0%
2/8
|
20.0%
2/10
|
16.7%
1/6
|
28.6%
4/14
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Cardiac disorders
Sinus arrthymia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
20.0%
2/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Skin infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Sore/lesion on buttocks
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
7.1%
1/14
|
|
Hepatobiliary disorders
Splenomegaly
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Stroke
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Infections and infestations
Submandibular gland infection
|
0.00%
0/4
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Substernal pain
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Psychiatric disorders
Suicide
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
General disorders
Supraglottal edema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Supratentorial ventriculomegaly
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Eye disorders
Swollen, irritated eyes
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Nervous system disorders
Syncope
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Cardiac disorders
Tachycardia
|
100.0%
4/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Taste alteration
|
0.00%
0/4
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Nervous system disorders
Tingling left leg
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Tracheostomy
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
16.7%
1/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Urination difficult
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4
|
33.3%
1/3
|
50.0%
3/6
|
12.5%
1/8
|
50.0%
5/10
|
33.3%
2/6
|
28.6%
4/14
|
|
Reproductive system and breast disorders
Vulvar lesions
|
25.0%
1/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Investigations
Weight loss
|
0.00%
0/4
|
33.3%
1/3
|
0.00%
0/6
|
12.5%
1/8
|
10.0%
1/10
|
0.00%
0/6
|
0.00%
0/14
|
|
Infections and infestations
Yeast infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Petechia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/6
|
7.1%
1/14
|
Additional Information
Geoffrey Uy, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place