Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)

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: NCT00907517
Recruitment Status : Terminated
First Posted : May 22, 2009
Results First Posted : January 25, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelogenous Leukemia, Acute
Leukemia, Lymphocytic, Acute
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Myelogenous Leukemia, Chronic, Aggressive Phase
Interventions Drug: MK-8776
Drug: Cytarabine
Enrollment 24
Recruitment Details  
Pre-assignment Details Only one combination treatment cycle of approximately 4 to 6 weeks duration was anticipated, but participants may have received additional cycles of treatment if clinically indicated after discussion between the Investigator and the Sponsor.
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Hide Arm/Group Description Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Period Title: Overall Study
Started 3 3 6 6 6
Completed 0 0 2 2 1
Not Completed 3 3 4 4 5
Reason Not Completed
Progressive Disease             3             3             4             4             4
Symptomatic Deterioration             0             0             0             0             1
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2 Total
Hide Arm/Group Description Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Total of all reporting groups
Overall Number of Baseline Participants 3 3 6 6 6 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants 6 participants 6 participants 24 participants
59.3  (9.1) 55.7  (1.5) 44.2  (14.2) 57.5  (18.3) 56.3  (13.5) 53.9  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 6 participants 6 participants 24 participants
Female
1
  33.3%
3
 100.0%
2
  33.3%
4
  66.7%
3
  50.0%
13
  54.2%
Male
2
  66.7%
0
   0.0%
4
  66.7%
2
  33.3%
3
  50.0%
11
  45.8%
1.Primary Outcome
Title Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Hide Description Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.
Time Frame Throughout Cycle 1 (Up to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Hide Arm/Group Description:
Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Overall Number of Participants Analyzed 3 3 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 3
2.Primary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.
Time Frame Up to 45 days after last dose of study treatment (Up to 180 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Hide Arm/Group Description:
Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Overall Number of Participants Analyzed 3 3 6 6 6
Measure Type: Number
Unit of Measure: Participants
3 3 6 6 6
3.Primary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.
Time Frame Up to 135 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received at least one dose of study treatment.
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Hide Arm/Group Description:
Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Overall Number of Participants Analyzed 3 3 6 6 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0
Time Frame Up to 45 days after last dose of study treatment (Up to 180 days)
Adverse Event Reporting Description The population consisted of all participants who received at least one dose of study treatment.
 
Arm/Group Title MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Hide Arm/Group Description Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
All-Cause Mortality
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      1/6 (16.67%)      2/6 (33.33%)      1/6 (16.67%)    
Blood and lymphatic system disorders           
FEBRILE NEUTROPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders           
GASTRITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
NAUSEA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
VOMITING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Infections and infestations           
FUNGAL INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PNEUMONIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PNEUMONIA FUNGAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications           
SUBDURAL HAEMATOMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nervous system disorders           
HEADACHE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Renal and urinary disorders           
RENAL FAILURE ACUTE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
PULMONARY OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Vascular disorders           
HYPERTENSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 MK-8776 140 mg + Cytarabine 2 g/m^2
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%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders           
ANAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  3 0/6 (0.00%)  0
DISSEMINATED INTRAVASCULAR COAGULATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
FEBRILE NEUTROPENIA  1  1/3 (33.33%)  1 2/3 (66.67%)  2 5/6 (83.33%)  6 3/6 (50.00%)  5 5/6 (83.33%)  7
LEUKOPENIA  1  1/3 (33.33%)  2 1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
LYMPHOPENIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
NEUTROPENIA  1  1/3 (33.33%)  4 1/3 (33.33%)  1 1/6 (16.67%)  1 2/6 (33.33%)  4 0/6 (0.00%)  0
SPLENOMEGALY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
THROMBOCYTOPENIA  1  1/3 (33.33%)  16 1/3 (33.33%)  1 1/6 (16.67%)  6 1/6 (16.67%)  3 1/6 (16.67%)  2
Cardiac disorders           
CARDIOMEGALY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
EXTRASYSTOLES  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PERICARDIAL EFFUSION  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
TRICUSPID VALVE INCOMPETENCE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Ear and labyrinth disorders           
EAR PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HYPOACUSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Endocrine disorders           
DIABETES INSIPIDUS  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Eye disorders           
CONJUNCTIVAL HAEMORRHAGE  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
CONJUNCTIVITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
DRY EYE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
PERIORBITAL OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
VISUAL IMPAIRMENT  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Gastrointestinal disorders           
ABDOMINAL PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3 0/6 (0.00%)  0
ABDOMINAL PAIN UPPER  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
ABDOMINAL TENDERNESS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
CONSTIPATION  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  2 2/6 (33.33%)  2
DIARRHOEA  1  1/3 (33.33%)  1 1/3 (33.33%)  1 4/6 (66.67%)  4 4/6 (66.67%)  6 2/6 (33.33%)  3
DRY MOUTH  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0
DYSPEPSIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
EPIGASTRIC DISCOMFORT  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1
GINGIVAL BLEEDING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
HAEMORRHOIDS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
MELAENA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
MOUTH HAEMORRHAGE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
NAUSEA  1  1/3 (33.33%)  2 1/3 (33.33%)  1 4/6 (66.67%)  7 5/6 (83.33%)  5 5/6 (83.33%)  6
OESOPHAGEAL ULCER  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
PROCTALGIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
RECTAL HAEMORRHAGE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
SALIVARY HYPERSECRETION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
STOMATITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
VOMITING  1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/6 (50.00%)  7 4/6 (66.67%)  4 1/6 (16.67%)  1
General disorders           
CATHETER SITE ERYTHEMA  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
CHILLS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
FATIGUE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 2/6 (33.33%)  2 3/6 (50.00%)  3
MALAISE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
MUCOSAL INFLAMMATION  1  2/3 (66.67%)  12 1/3 (33.33%)  1 2/6 (33.33%)  3 4/6 (66.67%)  5 0/6 (0.00%)  0
NODULE  1  0/3 (0.00%)  0 1/3 (33.33%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
OEDEMA PERIPHERAL  1  0/3 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  1 2/6 (33.33%)  3 1/6 (16.67%)  2
PAIN  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PYREXIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  9 2/6 (33.33%)  2 0/6 (0.00%)  0
Hepatobiliary disorders           
HYPERBILIRUBINAEMIA  1  2/3 (66.67%)  8 1/3 (33.33%)  1 2/6 (33.33%)  12 1/6 (16.67%)  3 2/6 (33.33%)  2
Infections and infestations           
BACTERAEMIA  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
CANDIDIASIS  1  2/3 (66.67%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0
CELLULITIS ORBITAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1
FUNGAEMIA  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
MASTOIDITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PNEUMONIA  1  1/3 (33.33%)  1 2/3 (66.67%)  2 2/6 (33.33%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1
PNEUMONIA FUNGAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
SEPSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
SINUSITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
STAPHYLOCOCCAL INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
TINEA INFECTION  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
TOOTH ABSCESS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications           
EYE INJURY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PERIORBITAL HAEMATOMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PROCEDURAL PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
RIB FRACTURE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
TRANSFUSION REACTION  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0
Investigations           
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
ALANINE AMINOTRANSFERASE INCREASED  1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/6 (50.00%)  10 2/6 (33.33%)  7 0/6 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/6 (50.00%)  8 2/6 (33.33%)  9 0/6 (0.00%)  0
BLOOD ALKALINE PHOSPHATASE INCREASED  1  1/3 (33.33%)  3 1/3 (33.33%)  3 2/6 (33.33%)  6 4/6 (66.67%)  5 0/6 (0.00%)  0
BLOOD BILIRUBIN INCREASED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
BLOOD CREATININE DECREASED  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
BLOOD CREATININE INCREASED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 3/6 (50.00%)  5 1/6 (16.67%)  3
CARDIAC MURMUR  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
EJECTION FRACTION DECREASED  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
ELECTROCARDIOGRAM QT PROLONGED  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
FUNGAL TEST POSITIVE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
INTERNATIONAL NORMALISED RATIO INCREASED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  3 0/6 (0.00%)  0
TROPONIN INCREASED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
WEIGHT DECREASED  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
WHITE BLOOD CELL COUNT INCREASED  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders           
DECREASED APPETITE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1
DEHYDRATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
FLUID OVERLOAD  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
FLUID RETENTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HYPERALBUMINAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HYPERCHOLESTEROLAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
HYPERGLYCAEMIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  3 1/6 (16.67%)  6 0/6 (0.00%)  0
HYPERPHOSPHATAEMIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2
HYPERTRIGLYCERIDAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
HYPOALBUMINAEMIA  1  2/3 (66.67%)  5 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
HYPOCALCAEMIA  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
HYPOKALAEMIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/6 (50.00%)  4 2/6 (33.33%)  7 1/6 (16.67%)  3
HYPOMAGNESAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  4
HYPONATRAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0
HYPOPHAGIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
HYPOPHOSPHATAEMIA  1  1/3 (33.33%)  2 1/3 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
TUMOUR LYSIS SYNDROME  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
BACK PAIN  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
BONE PAIN  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
MUSCLE SPASMS  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
MUSCULAR WEAKNESS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
MUSCULOSKELETAL PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PAIN IN EXTREMITY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3
TENDONITIS  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders           
DIZZINESS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
DYSGEUSIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HEADACHE  1  1/3 (33.33%)  1 1/3 (33.33%)  1 3/6 (50.00%)  5 2/6 (33.33%)  3 1/6 (16.67%)  1
MIGRAINE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
NEUROPATHY PERIPHERAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Psychiatric disorders           
ABNORMAL DREAMS  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
AGITATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
ANXIETY  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
DELIRIUM  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1
DEPRESSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
HALLUCINATION, AUDITORY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
INSOMNIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0 1/6 (16.67%)  2
Renal and urinary disorders           
BLADDER PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
CYSTITIS HAEMORRHAGIC  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
DYSURIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
HAEMATURIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
HYDRONEPHROSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
INCONTINENCE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
NEPHROGENIC DIABETES INSIPIDUS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
NEUROGENIC BLADDER  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
RENAL FAILURE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Reproductive system and breast disorders           
BREAST CYST  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
UTERINE HAEMORRHAGE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
VAGINAL HAEMORRHAGE  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders           
COUGH  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
DYSPNOEA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  3 1/6 (16.67%)  1
DYSPNOEA EXERTIONAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1
EPISTAXIS  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
HAEMOPTYSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
HYPOXIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
NASAL CONGESTION  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
NASAL DRYNESS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
OROPHARYNGEAL PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
PARANASAL SINUS HYPERSECRETION  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
PLEURAL EFFUSION  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
PLEURITIC PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
PULMONARY HYPERTENSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PULMONARY OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
SINUS CONGESTION  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
THROAT IRRITATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
UPPER-AIRWAY COUGH SYNDROME  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
WHEEZING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders           
ALOPECIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
DRUG ERUPTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  2
PRURITUS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1
RASH  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 3/6 (50.00%)  3
RASH ERYTHEMATOUS  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
RASH GENERALISED  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
RASH PRURITIC  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
SKIN EXFOLIATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
SKIN MASS  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders           
HYPERTENSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 5/6 (83.33%)  10 0/6 (0.00%)  0
HYPOTENSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
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: NCT00907517     History of Changes
Other Study ID Numbers: P05247
MK-8776-001 ( Other Identifier: Merck Protocol Number )
First Submitted: May 21, 2009
First Posted: May 22, 2009
Results First Submitted: November 30, 2016
Results First Posted: January 25, 2017
Last Update Posted: August 27, 2018