Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00479232
Recruitment Status : Completed
First Posted : May 28, 2007
Results First Posted : August 31, 2011
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Myelocytic, Acute Myelodysplastic Syndromes
Myelodysplastic Syndromes
Interventions Drug: vorinostat
Drug: decitabine
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
Hide Arm/Group Description (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 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 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 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 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 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.
Period Title: Overall Study
Started 3 3 28 3 4 30
Completed 0 0 0 0 0 0
Not Completed 3 3 28 3 4 30
Reason Not Completed
Adverse Event             0             0             5             0             0             10
Deviation from Protocol             0             0             1             0             0             0
Lack of Efficacy             0             0             2             0             0             4
Physician Decision             0             0             2             0             0             1
Progressive Disease             3             1             12             3             3             12
Withdrew Consent             0             2             6             0             1             3
Arm/Group Title Vorinostat + Decitabine, Concurrent Vorinostat + Decitabine, Sequential Total
Hide Arm/Group Description (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. (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 of all reporting groups
Overall Number of Baseline Participants 34 37 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 37 participants 71 participants
63.9  (13.0) 66.6  (13.8) 65.3  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 participants
Female
11
  32.4%
18
  48.6%
29
  40.8%
Male
23
  67.6%
19
  51.4%
42
  59.2%
1.Primary Outcome
Title Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Hide Description 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.
Time Frame Day 1 to 28 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)
Hide Arm/Group Description:
(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 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 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 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 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 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.
Overall Number of Participants Analyzed 3 3 28 3 4 30
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 1
2.Other Pre-specified Outcome
Title Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)
Hide Description Objective 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.
Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory or Relapsed AML, Concurrent Refractory or Relapsed AML, Sequential
Hide Arm/Group Description:
Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: percentage of participants
7.1 0.0
3.Other Pre-specified Outcome
Title Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)
Hide Description Objective 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.
Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Untreated AML or Intermediate, Concurrent Untreated AML or Intermediate, Sequential
Hide Arm/Group Description:

Participants with Untreated AML or Intermediate-High

Risk MDS who were treated with vorinostat and Decitabine

concurrently.

Participants with Untreated AML or Intermediate-High

Risk MDS who were treated with vorinostat and Decitabine

sequentially.

Overall Number of Participants Analyzed 20 22
Measure Type: Number
Unit of Measure: percentage of participants
35.0 13.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Hide Arm/Group Description (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 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 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 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 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) 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.
All-Cause Mortality
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/3 (33.33%)      21/28 (75.00%)      2/3 (66.67%)      4/4 (100.00%)      25/31 (80.65%)    
Blood and lymphatic system disorders             
Febrile neutropenia  1  1/3 (33.33%)  2 1/3 (33.33%)  1 12/28 (42.86%)  16 1/3 (33.33%)  1 1/4 (25.00%)  1 7/31 (22.58%)  8
Leukopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Thrombocytosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Cardiac disorders             
Acute myocardial infarction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Atrial fibrillation  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Cardiac arrest  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Myocardial infarction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Pericardial effusion  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Sinus bradycardia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal disorders             
Caecitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Haematemesis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Nausea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Pancreatitis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Small intestinal obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
General disorders             
Death  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Multi-organ failure  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0 3/31 (9.68%)  5
Hepatobiliary disorders             
Cholecystitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Infections and infestations             
Bacterial sepsis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0 2/31 (6.45%)  2
Clostridium bacteraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Enterococcal bacteraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Enterococcal infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Gastroenteritis clostridial  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Klebsiella infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Klebsiella sepsis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Lung infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Oesophageal candidiasis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Perirectal abscess  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Pneumonia  1  3/3 (100.00%)  3 0/3 (0.00%)  0 6/28 (21.43%)  7 0/3 (0.00%)  0 2/4 (50.00%)  4 1/31 (3.23%)  1
Pneumonia fungal  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Pneumonia primary atypical  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Sepsis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Staphylococcal bacteraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Streptococcal bacteraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Urinary tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Urosepsis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Injury, poisoning and procedural complications             
Spinal compression fracture  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Investigations             
Electrocardiogram QT prolonged  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Metabolism and nutrition disorders             
Dehydration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Hyponatraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Myositis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Acute myeloid leukaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/28 (7.14%)  2 1/3 (33.33%)  1 1/4 (25.00%)  1 3/31 (9.68%)  3
Myelofibrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Squamous cell carcinoma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders             
Cerebral infarction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Cerebrovascular accident  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Dizziness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Syncope  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Psychiatric disorders             
Mental status changes  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Renal and urinary disorders             
Haematuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Renal failure  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Renal failure acute  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Pulmonary embolism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Respiratory failure  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders             
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Rash  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Vascular disorders             
Deep vein thrombosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Orthostatic hypotension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Thrombophlebitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD) Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      27/28 (96.43%)      3/3 (100.00%)      4/4 (100.00%)      29/31 (93.55%)    
Blood and lymphatic system disorders             
Anaemia  1  2/3 (66.67%)  2 1/3 (33.33%)  3 3/28 (10.71%)  6 2/3 (66.67%)  2 1/4 (25.00%)  1 3/31 (9.68%)  3
Febrile neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  2 0/4 (0.00%)  0 3/31 (9.68%)  4
Granulocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  4 0/4 (0.00%)  0 0/31 (0.00%)  0
Leukopenia  1  2/3 (66.67%)  2 2/3 (66.67%)  10 8/28 (28.57%)  17 2/3 (66.67%)  4 1/4 (25.00%)  1 3/31 (9.68%)  5
Lymphadenopathy  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Neutropenia  1  0/3 (0.00%)  0 3/3 (100.00%)  6 9/28 (32.14%)  20 0/3 (0.00%)  0 0/4 (0.00%)  0 6/31 (19.35%)  12
Thrombocytopenia  1  0/3 (0.00%)  0 1/3 (33.33%)  5 11/28 (39.29%)  31 1/3 (33.33%)  2 1/4 (25.00%)  1 8/31 (25.81%)  20
Cardiac disorders             
Arrhythmia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/31 (0.00%)  0
Palpitations  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Sinus bradycardia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Sinus tachycardia  1  3/3 (100.00%)  4 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/31 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Ear and labyrinth disorders             
Ear pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Eye disorders             
Cataract  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Conjunctivitis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Retinopathy  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Vision blurred  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Vitreous floaters  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal disorders             
Abdominal discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 1/4 (25.00%)  1 3/31 (9.68%)  3
Abdominal distension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 3/31 (9.68%)  3
Abdominal pain  1  1/3 (33.33%)  1 1/3 (33.33%)  1 7/28 (25.00%)  7 1/3 (33.33%)  1 1/4 (25.00%)  3 3/31 (9.68%)  3
Abdominal pain lower  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Abdominal pain upper  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 2/31 (6.45%)  2
Cheilitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Constipation  1  2/3 (66.67%)  2 0/3 (0.00%)  0 16/28 (57.14%)  24 1/3 (33.33%)  2 3/4 (75.00%)  5 11/31 (35.48%)  15
Diarrhoea  1  2/3 (66.67%)  3 3/3 (100.00%)  4 16/28 (57.14%)  25 1/3 (33.33%)  1 3/4 (75.00%)  3 15/31 (48.39%)  21
Dry mouth  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  3
Dyspepsia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 3/4 (75.00%)  3 1/31 (3.23%)  1
Eructation  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Flatulence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  3
Gastrooesophageal reflux disease  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/31 (0.00%)  0
Gingival bleeding  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Gingivitis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Haemorrhoids  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/28 (17.86%)  5 0/3 (0.00%)  0 1/4 (25.00%)  1 3/31 (9.68%)  3
Lip dry  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Melaena  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Mouth haemorrhage  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  2
Nausea  1  2/3 (66.67%)  3 1/3 (33.33%)  2 17/28 (60.71%)  29 3/3 (100.00%)  3 3/4 (75.00%)  4 20/31 (64.52%)  25
Oral pain  1  1/3 (33.33%)  1 1/3 (33.33%)  1 2/28 (7.14%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Proctalgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Rectal haemorrhage  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Vomiting  1  1/3 (33.33%)  1 1/3 (33.33%)  1 10/28 (35.71%)  15 2/3 (66.67%)  2 2/4 (50.00%)  3 11/31 (35.48%)  12
General disorders             
Asthenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 7/28 (25.00%)  7 0/3 (0.00%)  0 2/4 (50.00%)  2 4/31 (12.90%)  4
Catheter site erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Catheter site pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Chest discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Chest pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/28 (7.14%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Chills  1  0/3 (0.00%)  0 1/3 (33.33%)  1 11/28 (39.29%)  12 1/3 (33.33%)  1 1/4 (25.00%)  2 2/31 (6.45%)  3
Fatigue  1  3/3 (100.00%)  3 1/3 (33.33%)  1 11/28 (39.29%)  20 2/3 (66.67%)  2 3/4 (75.00%)  4 19/31 (61.29%)  24
Gait disturbance  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Infusion site pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Injection site pruritus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Mucosal inflammation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  2 1/3 (33.33%)  1 1/4 (25.00%)  1 2/31 (6.45%)  2
Oedema  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/28 (3.57%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 2/31 (6.45%)  2
Oedema peripheral  1  1/3 (33.33%)  1 0/3 (0.00%)  0 5/28 (17.86%)  6 0/3 (0.00%)  0 1/4 (25.00%)  1 7/31 (22.58%)  9
Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 4/31 (12.90%)  4
Pyrexia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 7/28 (25.00%)  9 0/3 (0.00%)  0 0/4 (0.00%)  0 5/31 (16.13%)  5
Hepatobiliary disorders             
Hyperbilirubinaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 7/28 (25.00%)  10 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations             
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 2/31 (6.45%)  2
Diverticulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Folliculitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Oral herpes  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Paronychia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Urinary tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Vulvovaginal mycotic infection  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Injury, poisoning and procedural complications             
Contusion  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Excoriation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  2 0/31 (0.00%)  0
Wound  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 4/28 (14.29%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  17
Aspartate aminotransferase increased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/28 (10.71%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  7
Blood alkaline phosphatase increased  1  2/3 (66.67%)  2 0/3 (0.00%)  0 2/28 (7.14%)  2 1/3 (33.33%)  2 0/4 (0.00%)  0 1/31 (3.23%)  3
Blood bicarbonate decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  2 1/3 (33.33%)  2 1/4 (25.00%)  1 0/31 (0.00%)  0
Blood calcium decreased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Blood creatinine increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/28 (14.29%)  6 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  4
Blood glucose increased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Blood potassium decreased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Electrocardiogram QT prolonged  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Gamma-glutamyltransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  6
Granulocyte count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Haemoglobin decreased  1  1/3 (33.33%)  2 1/3 (33.33%)  1 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/31 (3.23%)  2
Neutrophil count decreased  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Platelet count decreased  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Prothrombin time prolonged  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Weight decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/28 (14.29%)  4 1/3 (33.33%)  1 0/4 (0.00%)  0 1/31 (3.23%)  1
Weight increased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
White blood cell count decreased  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/28 (0.00%)  0 2/3 (66.67%)  3 0/4 (0.00%)  0 0/31 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  1/3 (33.33%)  1 2/3 (66.67%)  2 9/28 (32.14%)  14 2/3 (66.67%)  2 1/4 (25.00%)  1 10/31 (32.26%)  13
Dehydration  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Diabetes mellitus  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Fluid retention  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Haemosiderosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Hyperglycaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 5/28 (17.86%)  6 2/3 (66.67%)  4 1/4 (25.00%)  2 2/31 (6.45%)  2
Hyperkalaemia  1  1/3 (33.33%)  1 1/3 (33.33%)  1 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Hypermagnesaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Hypoalbuminaemia  1  2/3 (66.67%)  2 0/3 (0.00%)  0 5/28 (17.86%)  6 2/3 (66.67%)  2 1/4 (25.00%)  1 2/31 (6.45%)  4
Hypocalcaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 3/3 (100.00%)  5 0/4 (0.00%)  0 2/31 (6.45%)  6
Hypokalaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 7/28 (25.00%)  13 2/3 (66.67%)  2 1/4 (25.00%)  1 6/31 (19.35%)  8
Hypomagnesaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  5
Hyponatraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/28 (17.86%)  8 2/3 (66.67%)  2 1/4 (25.00%)  1 4/31 (12.90%)  5
Hypophagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Hypophosphataemia  1  2/3 (66.67%)  2 1/3 (33.33%)  1 4/28 (14.29%)  5 3/3 (100.00%)  4 2/4 (50.00%)  2 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/3 (33.33%)  1 1/3 (33.33%)  1 6/28 (21.43%)  6 1/3 (33.33%)  1 0/4 (0.00%)  0 3/31 (9.68%)  10
Back pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 5/28 (17.86%)  6 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  4
Bone pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Muscle spasms  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Muscular weakness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Musculoskeletal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Myalgia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 4/28 (14.29%)  4 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Neck pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 2/3 (66.67%)  2 3/28 (10.71%)  3 1/3 (33.33%)  1 0/4 (0.00%)  0 4/31 (12.90%)  8
Pain in jaw  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 0/31 (0.00%)  0
Rhabdomyolysis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Nervous system disorders             
Dizziness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 11/28 (39.29%)  16 0/3 (0.00%)  0 1/4 (25.00%)  1 7/31 (22.58%)  9
Dysgeusia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Headache  1  3/3 (100.00%)  3 2/3 (66.67%)  3 7/28 (25.00%)  9 1/3 (33.33%)  1 0/4 (0.00%)  0 5/31 (16.13%)  6
Hypoaesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Neuropathy peripheral  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Paraesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/31 (3.23%)  1
Somnolence  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Tremor  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/28 (14.29%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Psychiatric disorders             
Agitation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Anxiety  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Confusional state  1  1/3 (33.33%)  1 0/3 (0.00%)  0 4/28 (14.29%)  6 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Depression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 4/31 (12.90%)  4
Hallucination, visual  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Insomnia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 4/28 (14.29%)  5 1/3 (33.33%)  1 1/4 (25.00%)  1 4/31 (12.90%)  4
Renal and urinary disorders             
Bladder spasm  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Dysuria  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 2/31 (6.45%)  2
Haematuria  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  3
Pollakiuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Urinary hesitation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Urinary incontinence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 2/31 (6.45%)  2
Reproductive system and breast disorders             
Testis discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Vulvovaginal pruritus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/3 (66.67%)  3 1/3 (33.33%)  1 6/28 (21.43%)  6 1/3 (33.33%)  1 2/4 (50.00%)  2 9/31 (29.03%)  9
Dyspnoea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 2/4 (50.00%)  3 3/31 (9.68%)  3
Dyspnoea exertional  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  4 1/3 (33.33%)  1 1/4 (25.00%)  1 2/31 (6.45%)  2
Epistaxis  1  1/3 (33.33%)  2 0/3 (0.00%)  0 3/28 (10.71%)  4 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Haemoptysis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Oropharyngeal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 6/31 (19.35%)  6
Painful respiration  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Pleuritic pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 1/4 (25.00%)  2 2/31 (6.45%)  3
Pulmonary oedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Respiratory distress  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Respiratory failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Rhinitis allergic  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Rhinorrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Sinus congestion  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/28 (7.14%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Wheezing  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders             
Dry skin  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  2
Ecchymosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/28 (10.71%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Hyperhidrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Increased tendency to bruise  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 1/31 (3.23%)  1
Night sweats  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Petechiae  1  2/3 (66.67%)  2 0/3 (0.00%)  0 1/28 (3.57%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 3/31 (9.68%)  3
Pruritus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  2
Rash  1  0/3 (0.00%)  0 2/3 (66.67%)  2 4/28 (14.29%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0 4/31 (12.90%)  4
Rash generalised  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 1/4 (25.00%)  1 0/31 (0.00%)  0
Rash macular  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Vascular disorders             
Deep vein thrombosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/28 (7.14%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Flushing  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/28 (3.57%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 1/31 (3.23%)  1
Haematoma  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/31 (0.00%)  0
Hypertension  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/28 (7.14%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0 4/31 (12.90%)  6
Hypotension  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/28 (3.57%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/31 (9.68%)  3
Thrombosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/28 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/31 (6.45%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00479232     History of Changes
Other Study ID Numbers: 0683-055
2007_500
First Submitted: May 24, 2007
First Posted: May 28, 2007
Results First Submitted: April 28, 2011
Results First Posted: August 31, 2011
Last Update Posted: September 21, 2015