Trial Outcomes & Findings for Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1) (NCT NCT00479232)
NCT ID: NCT00479232
Last Updated: 2015-09-21
Results Overview
Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m\^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting \>42 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
71 participants
Primary outcome timeframe
Day 1 to 28 of Cycle 1
Results posted on
2015-09-21
Participant Flow
Participant milestones
| Measure |
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine
(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine
(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
28
|
3
|
4
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
28
|
3
|
4
|
30
|
Reasons for withdrawal
| Measure |
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine
(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine
(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
5
|
0
|
0
|
10
|
|
Overall Study
Deviation from Protocol
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
3
|
1
|
12
|
3
|
3
|
12
|
|
Overall Study
Withdrew Consent
|
0
|
2
|
6
|
0
|
1
|
3
|
Baseline Characteristics
Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)
Baseline characteristics by cohort
| Measure |
Vorinostat + Decitabine, Concurrent
n=34 Participants
(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
|
Vorinostat + Decitabine, Sequential
n=37 Participants
(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m\^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 28 of Cycle 1Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m\^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting \>42 days.
Outcome measures
| Measure |
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine
n=3 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine
n=3 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
n=28 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine
n=3 Participants
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine
n=4 Participants
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
n=30 Participants
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 6 monthsObjective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.
Outcome measures
| Measure |
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine
n=14 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine
n=15 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)
|
7.1 percentage of participants
0 • Interval 0.2 to 33.9
|
0.0 percentage of participants
NA • Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 6 monthsObjective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.
Outcome measures
| Measure |
Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine
n=20 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine
n=22 Participants
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)
|
35.0 percentage of participants
170.3
|
13.6 percentage of participants
119.2
|
—
|
—
|
—
|
—
|
Adverse Events
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Serious events: 21 serious events
Other events: 27 other events
Deaths: 0 deaths
Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Serious events: 25 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine
n=3 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine
n=3 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
n=28 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine
n=3 participants at risk
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine
n=4 participants at risk
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
n=31 participants at risk
(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
42.9%
12/28 • Number of events 16
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
22.6%
7/31 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Cardiac disorders
Atrial fibrillation
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Death
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
General disorders
Multi-organ failure
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
9.7%
3/31 • Number of events 5
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
100.0%
3/3 • Number of events 3
|
0.00%
0/3
|
21.4%
6/28 • Number of events 7
|
0.00%
0/3
|
50.0%
2/4 • Number of events 4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
Other adverse events
| Measure |
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine
n=3 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine
n=3 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
n=28 participants at risk
(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine
n=3 participants at risk
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine
n=4 participants at risk
(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
n=31 participants at risk
(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m\^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
14.3%
4/28 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
12.9%
4/31 • Number of events 4
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Reproductive system and breast disorders
Testis discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
21.4%
6/28 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
29.0%
9/31 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
10.7%
3/28 • Number of events 4
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
19.4%
6/31 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
6.5%
2/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
7.1%
2/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
14.3%
4/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
12.9%
4/31 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.1%
2/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
12.9%
4/31 • Number of events 6
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
4/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
10.7%
3/28 • Number of events 6
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
9.7%
3/31 • Number of events 4
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 4
|
0.00%
0/4
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 10
|
28.6%
8/28 • Number of events 17
|
66.7%
2/3 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
100.0%
3/3 • Number of events 6
|
32.1%
9/28 • Number of events 20
|
0.00%
0/3
|
0.00%
0/4
|
19.4%
6/31 • Number of events 12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 5
|
39.3%
11/28 • Number of events 31
|
33.3%
1/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
25.8%
8/31 • Number of events 20
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
3/3 • Number of events 4
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Eye disorders
Conjunctivitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Eye disorders
Retinopathy
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
12.9%
4/31 • Number of events 4
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
14.3%
4/28 • Number of events 6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
7/28 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
57.1%
16/28 • Number of events 24
|
33.3%
1/3 • Number of events 2
|
75.0%
3/4 • Number of events 5
|
35.5%
11/31 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 3
|
100.0%
3/3 • Number of events 4
|
57.1%
16/28 • Number of events 25
|
33.3%
1/3 • Number of events 1
|
75.0%
3/4 • Number of events 3
|
48.4%
15/31 • Number of events 21
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
75.0%
3/4 • Number of events 3
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
0.00%
0/3
|
17.9%
5/28 • Number of events 5
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Lip dry
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
60.7%
17/28 • Number of events 29
|
100.0%
3/3 • Number of events 3
|
75.0%
3/4 • Number of events 4
|
64.5%
20/31 • Number of events 25
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
7.1%
2/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
35.7%
10/28 • Number of events 15
|
66.7%
2/3 • Number of events 2
|
50.0%
2/4 • Number of events 3
|
35.5%
11/31 • Number of events 12
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
7/28 • Number of events 7
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
12.9%
4/31 • Number of events 4
|
|
General disorders
Catheter site erythema
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
General disorders
Catheter site pain
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.1%
2/28 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
39.3%
11/28 • Number of events 12
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
6.5%
2/31 • Number of events 3
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
39.3%
11/28 • Number of events 20
|
66.7%
2/3 • Number of events 2
|
75.0%
3/4 • Number of events 4
|
61.3%
19/31 • Number of events 24
|
|
General disorders
Gait disturbance
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Infusion site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Injection site pruritus
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
17.9%
5/28 • Number of events 6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
22.6%
7/31 • Number of events 9
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
12.9%
4/31 • Number of events 4
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
7/28 • Number of events 9
|
0.00%
0/3
|
0.00%
0/4
|
16.1%
5/31 • Number of events 5
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
7/28 • Number of events 10
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Wound
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
14.3%
4/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 17
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.7%
3/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 7
|
|
Investigations
Blood alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
3.2%
1/31 • Number of events 3
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Blood calcium decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
4/28 • Number of events 6
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 4
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Blood potassium decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 6
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
3.2%
1/31 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
4/28 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
66.7%
2/3 • Number of events 3
|
0.00%
0/4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
32.1%
9/28 • Number of events 14
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
32.3%
10/31 • Number of events 13
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Fluid retention
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Haemosiderosis
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
17.9%
5/28 • Number of events 6
|
66.7%
2/3 • Number of events 4
|
25.0%
1/4 • Number of events 2
|
6.5%
2/31 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
17.9%
5/28 • Number of events 6
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
6.5%
2/31 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
100.0%
3/3 • Number of events 5
|
0.00%
0/4
|
6.5%
2/31 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
7/28 • Number of events 13
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
19.4%
6/31 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
17.9%
5/28 • Number of events 8
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
12.9%
4/31 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
14.3%
4/28 • Number of events 5
|
100.0%
3/3 • Number of events 4
|
50.0%
2/4 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
21.4%
6/28 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
9.7%
3/31 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
17.9%
5/28 • Number of events 6
|
0.00%
0/3
|
0.00%
0/4
|
9.7%
3/31 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 5
|
0.00%
0/3
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
14.3%
4/28 • Number of events 4
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
2/28 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
10.7%
3/28 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
12.9%
4/31 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3
|
0.00%
0/3
|
3.6%
1/28 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
39.3%
11/28 • Number of events 16
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
22.6%
7/31 • Number of events 9
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
25.0%
7/28 • Number of events 9
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
16.1%
5/31 • Number of events 6
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
10.7%
3/28 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/28
|
0.00%
0/3
|
0.00%
0/4
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/28
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
3.2%
1/31 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER