Trial Outcomes & Findings for Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy (NCT NCT00878722)
NCT ID: NCT00878722
Last Updated: 2015-07-28
Results Overview
DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
First Cycle
Results posted on
2015-07-28
Participant Flow
Participant milestones
| Measure |
Arm A, Step 1
PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
9
|
7
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
9
|
7
|
2
|
6
|
7
|
Reasons for withdrawal
| Measure |
Arm A, Step 1
PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
3
|
3
|
3
|
7
|
7
|
1
|
4
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Relapse
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy
Baseline characteristics by cohort
| Measure |
Arm A, Step 1
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=9 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=6 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=7 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: First CycleDLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle
Outcome measures
| Measure |
Arm A, Step 1
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=9 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=6 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=7 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose, Dose Limiting Toxicity
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycleEfficacy measured as Response rate (complete response (\[CR\] and Complete remission with incomplete recovery of platelets \[CRi\]) and partial response (\[PR\])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission).
Outcome measures
| Measure |
Arm A, Step 1
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=9 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=6 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=7 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cyclePopulation: Time to response was reported among participants who reported response
Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR)
Outcome measures
| Measure |
Arm A, Step 1
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=1 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Time to Response (CR and PR)
|
—
|
2.6 Weeks
Only 1 patient analyzed
|
7.9 Weeks
Only 1 patient analyzed
|
6.0 Weeks
Only 1 patient analyzed
|
4.0 Weeks
Only 1 patient analyzed
|
1.9 Weeks
Only 1 patient analyzed
|
4.0 Weeks
Only 1 patient analyzed
|
1.0 Weeks
Interval 0.6 to 2.1
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cyclePopulation: All patients who received at least one dose of belinostat and/or idarubicin were included in the full analysis set (FAS). Duration of response was reported among participants who reported response
Duration of Response (CR and PR) in Weeks
Outcome measures
| Measure |
Arm A, Step 1
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=1 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (CR and PR)
|
—
|
26.3 weeks
|
20.6 weeks
|
28.1 weeks
|
5.4 weeks
|
30.3 weeks
|
19.6 weeks
|
4.3 weeks
Interval 3.0 to 6.1
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycleOverall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored.
Outcome measures
| Measure |
Arm A, Step 1
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=2 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
—
|
—
|
—
|
10 Weeks
Interval 3.0 to 10.3
|
4.9 Weeks
Interval 2.0 to 7.9
|
3.7 Weeks
Interval 3.7 to 3.7
|
—
|
3.9 Weeks
Interval 0.7 to 9.9
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cyclePopulation: Relapse free survival was reported among participants who reported response
Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause.
Outcome measures
| Measure |
Arm A, Step 1
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Relapse-Free Survival
|
—
|
26.3 Weeks
|
20.6 Weeks
|
28.1 Weeks
|
—
|
30.3 Weeks
|
—
|
6.1 Weeks
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycleEvent-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause.
Outcome measures
| Measure |
Arm A, Step 1
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=8 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=5 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=5 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Event-Free Survival
|
5.1 Weeks
Interval 2.1 to 10.9
|
3.1 Weeks
Interval 1.9 to 28.7
|
8.0 Weeks
Interval 6.7 to 28.3
|
6.5 Weeks
Interval 3.0 to 10.3
|
2.0 Weeks
Interval 0.4 to 7.9
|
5.4 Weeks
Interval 3.4 to 32.1
|
5.4 Weeks
Interval 4.1 to 26.0
|
6.4 Weeks
Interval 0.7 to 9.9
|
SECONDARY outcome
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cyclePopulation: Remission duration was reported among participants who reported response
Remission duration: time (weeks) from date of remission status to disease relapse.
Outcome measures
| Measure |
Arm A, Step 1
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=1 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=1 Participants
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=1 Participants
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Remission Duration
|
—
|
26.3 Weeks
Only 1 patient analyzed
|
20.6 Weeks
Only 1 patient analyzed
|
—
|
5.4 Weeks
Only 1 patient analyzed
|
30.3 Weeks
Only 1 patient analyzed
|
19.6 Weeks
Only 1 patient analyzed
|
3.0 Weeks
Only 1 patient analyzed
|
SECONDARY outcome
Timeframe: Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusionPopulation: Results shown for dose level 1000 mg/m2/d
Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2
Outcome measures
| Measure |
Arm A, Step 1
n=18 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=17 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=15 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Belinostat Cmax
|
38744 ng/mL
Standard Deviation 22653
|
31952 ng/mL
Standard Deviation 16319
|
9657 ng/mL
Standard Deviation 18859
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusionPopulation: Results shown for dose level 1000 mg/m2/d
Outcome measures
| Measure |
Arm A, Step 1
n=18 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=17 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=15 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Belinostat AUC (Area Under Curve)
|
21850 ng*hrs/mL
Standard Deviation 10327
|
21322 ng*hrs/mL
Standard Deviation 7516
|
172823 ng*hrs/mL
Standard Deviation 280715
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusionPopulation: Results shown for dose level 1000 mg/m2/d
Outcome measures
| Measure |
Arm A, Step 1
n=18 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=17 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=15 Participants
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Elimination t½
|
12.7 Hours
Standard Deviation 12.2
|
13.1 Hours
Standard Deviation 10.2
|
4.21 Hours
Standard Deviation 2.66
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A, Step 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A, Step 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A, Step 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A, Step 4
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B, Steps 1-6
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm B, Step 7
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B, Step 8
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm B, Step 9
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A, Step 1
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=9 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 participants at risk
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=6 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=7 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3
|
0.00%
0/3
|
66.7%
2/3
|
11.1%
1/9
|
14.3%
1/7
|
0.00%
0/3
|
33.3%
2/6
|
42.9%
3/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Anal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Central line infection
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Enterococcal bacteriaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Paronychia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Pulmonary mycosis
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
16.7%
1/6
|
28.6%
2/7
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
Other adverse events
| Measure |
Arm A, Step 1
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
|
Arm A, Step 2
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
|
Arm A, Step 3
n=3 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
|
Arm A, Step 4
n=9 participants at risk
PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
|
Arm B, Steps 1-6
n=7 participants at risk
PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
|
Arm B, Step 7
n=3 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 8
n=6 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
Arm B, Step 9
n=7 participants at risk
PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours
Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3
|
33.3%
1/3
|
66.7%
2/3
|
55.6%
5/9
|
28.6%
2/7
|
33.3%
1/3
|
50.0%
3/6
|
28.6%
2/7
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Spontaneous Hematoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3
|
66.7%
2/3
|
66.7%
2/3
|
33.3%
3/9
|
42.9%
3/7
|
0.00%
0/3
|
50.0%
3/6
|
57.1%
4/7
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Cardiac Disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Conduction Disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Myocardial Ischaemia
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Congenital, familial and genetic disorders
Antithrombin Iii Deficiency
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Eye disorders
Diplopia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Eye disorders
Dry eye
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Eye disorders
Visual Impairment
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3
|
33.3%
1/3
|
66.7%
2/3
|
11.1%
1/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
66.7%
2/3
|
66.7%
2/3
|
44.4%
4/9
|
28.6%
2/7
|
100.0%
3/3
|
83.3%
5/6
|
100.0%
7/7
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
42.9%
3/7
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
100.0%
3/3
|
66.7%
2/3
|
77.8%
7/9
|
42.9%
3/7
|
100.0%
3/3
|
83.3%
5/6
|
57.1%
4/7
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Tongue Blistering
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Tongue Discolouration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
100.0%
3/3
|
66.7%
2/3
|
55.6%
5/9
|
28.6%
2/7
|
66.7%
2/3
|
83.3%
5/6
|
71.4%
5/7
|
|
General disorders
Asthenia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Catheter Site Inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Chest Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Chills
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
14.3%
1/7
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/7
|
|
General disorders
Face Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
66.7%
4/6
|
14.3%
1/7
|
|
General disorders
Feeling Cold
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Generalised Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
28.6%
2/7
|
|
General disorders
Inflammation
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Influenza Like Illness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Infusion Site Pain
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Injection Site Reaction
|
33.3%
1/3
|
0.00%
0/3
|
66.7%
2/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Localised Oedema
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Malaise
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
14.3%
1/7
|
|
General disorders
Nodule
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
88.9%
8/9
|
28.6%
2/7
|
33.3%
1/3
|
50.0%
3/6
|
57.1%
4/7
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
66.7%
6/9
|
28.6%
2/7
|
66.7%
2/3
|
16.7%
1/6
|
71.4%
5/7
|
|
General disorders
Visceral Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Anal Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Central Line Infection
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Clostridium Bacteriaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Clostridium Difficilie Colitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Enteritis Infectious
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Enterobacter Bacteriaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Enterococcal Bacteriaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Impetigo
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Paronychia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Pulmonary Mycosis
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Puncture Site Infection
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
16.7%
1/6
|
28.6%
2/7
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Blood Creatinine Increased
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
33.3%
2/6
|
42.9%
3/7
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Investigations
Body Temperature Increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Central Venous Pressure Increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
28.6%
2/7
|
33.3%
1/3
|
50.0%
3/6
|
14.3%
1/7
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
33.3%
2/6
|
14.3%
1/7
|
|
Investigations
Heart Rate Increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Investigations
Ph Urine Deacreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Troponin T
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Investigations
Weight Decreased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Investigations
Weight Increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
28.6%
2/7
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/3
|
66.7%
2/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
33.3%
2/6
|
42.9%
3/7
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
14.3%
1/7
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
50.0%
3/6
|
71.4%
5/7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
100.0%
3/3
|
33.3%
1/3
|
22.2%
2/9
|
0.00%
0/7
|
33.3%
1/3
|
83.3%
5/6
|
71.4%
5/7
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
42.9%
3/7
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
33.3%
1/3
|
66.7%
2/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
50.0%
3/6
|
28.6%
2/7
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
28.6%
2/7
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Nervous system disorders
Movement Disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
14.3%
1/7
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Renal and urinary disorders
Urethral Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
22.2%
2/9
|
28.6%
2/7
|
33.3%
1/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
2/6
|
57.1%
4/7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
28.6%
2/7
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Blistering
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
14.3%
1/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
42.9%
3/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
22.2%
2/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
33.3%
2/6
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
33.3%
1/3
|
16.7%
1/6
|
28.6%
2/7
|
|
Social circumstances
Denture Wearer
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
33.3%
1/3
|
0.00%
0/6
|
14.3%
1/7
|
|
Vascular disorders
Hot Flush
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
11.1%
1/9
|
14.3%
1/7
|
33.3%
1/3
|
33.3%
2/6
|
28.6%
2/7
|
|
Vascular disorders
Hypotension
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Vascular disorders
Pallor
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/7
|
|
Vascular disorders
Phlebitis
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
11.1%
1/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3
|
0.00%
0/3
|
66.7%
2/3
|
22.2%
2/9
|
14.3%
1/7
|
0.00%
0/3
|
33.3%
2/6
|
42.9%
3/7
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
28.6%
2/7
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/9
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/6
|
14.3%
1/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60