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Trial record 1 of 1 for:    V934/V935
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A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

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: NCT00753415
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : June 3, 2014
Last Update Posted : March 17, 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 Non-Small Cell Lung Carcinoma
Breast Cancer
Melanoma
Upper GI Tract Carcinoma
Colon Carcinoma
Renal Cell Carcinoma
Bladder Carcinoma
Prostate Cancer
Interventions Biological: V935
Biological: V934-EP
Enrollment 37
Recruitment Details V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.
Pre-assignment Details Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V934 HD/V934 Booster
Hide Arm/Group Description Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period. Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period. Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period. Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Period Title: Part A
Started 3 3 10 11 10 0 0 0 0 0
Completed 2 3 8 9 10 0 0 0 0 0
Not Completed 1 0 2 2 0 0 0 0 0 0
Reason Not Completed
Disease progression             1             0             1             2             0             0             0             0             0             0
Withdrawal by Subject             0             0             1             0             0             0             0             0             0             0
Period Title: Part B
Started 0 0 0 0 0 1 [1] 2 [2] 7 [3] 9 [4] 9 [5]
Completed 0 0 0 0 0 1 2 6 6 8
Not Completed 0 0 0 0 0 0 0 1 3 1
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             0             0             1             1             0
Disease progression             0             0             0             0             0             0             0             0             2             1
[1]
Of 2 eligible participants who completed Part A, 1 chose to enter Part B
[2]
Of 3 eligible participants who completed Part A, 2 chose to enter Part B
[3]
Of 8 eligible participants who completed Part A, 7 chose to enter Part B
[4]
9 participants who completed Part A were eligible and enrolled in Part B
[5]
Of 10 eligible participants who completed Part A, 9 chose to enter Part B
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Total
Hide Arm/Group Description Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period. Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period. Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period. Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Total of all reporting groups
Overall Number of Baseline Participants 3 3 10 11 10 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 10 participants 11 participants 10 participants 37 participants
70.0  (9.5) 70.0  (6.2) 63.8  (10.0) 58.8  (11.7) 60.2  (11.7) 62.4  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 10 participants 11 participants 10 participants 37 participants
Female
0
   0.0%
1
  33.3%
4
  40.0%
4
  36.4%
1
  10.0%
10
  27.0%
Male
3
 100.0%
2
  66.7%
6
  60.0%
7
  63.6%
9
  90.0%
27
  73.0%
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicity (DLT)
Hide Description DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
Time Frame Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Hide Arm/Group Description:
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Overall Number of Participants Analyzed 3 3 10 11 10 1 2 7 9 9
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
Time Frame Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) population; all participants who received at least one vaccination.
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Hide Arm/Group Description:
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Overall Number of Participants Analyzed 3 3 10 11 10 1 2 7 9 9
Measure Type: Number
Unit of Measure: Participants
3 3 8 11 10 1 1 3 8 7
3.Secondary Outcome
Title Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
Hide Description An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
Time Frame From pre-vaccination to Week 69
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Hide Arm/Group Description:
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Adverse Event Reporting Description Participants who completed Part A had the option to enter Part B.
 
Arm/Group Title Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Hide Arm/Group Description Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period. Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period. Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period. Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period. Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks. Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
All-Cause Mortality
Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   1/3 (33.33%)      0/3 (0.00%)      2/10 (20.00%)      2/11 (18.18%)      1/10 (10.00%)      0/1 (0.00%)      0/2 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Cardiac disorders                     
Pericardial effusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Coronary artery stenosis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders                     
Upper gastrointestinal haemorrhage  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations                     
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Lobar pneumonia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Pneumonia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Investigations                     
Haematocrit decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Bladder cancer  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Psychiatric disorders                     
Depressed mood  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: V935 LD Part A: V934 LD(3)+V935 LD Part A: V935 HD Part A: V934 HD(3)+V935 HD Part A: V934 HD(5)+V935 HD Part B: V935 LD/V934 Booster Part B: V934 LD(3)+V935 LD/V934 Booster Part B: V935 HD/V934 Booster Part B: V934 HD(3)+V935 HD/V934 Booster Part B: V934 HD(5)+V935 HD/V934 Booster
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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%)      8/10 (80.00%)      11/11 (100.00%)      10/10 (100.00%)      1/1 (100.00%)      1/2 (50.00%)      3/7 (42.86%)      8/9 (88.89%)      7/9 (77.78%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Lymphopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 1/10 (10.00%)  4 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  2 1/9 (11.11%)  1
Neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Cardiac disorders                     
Atrial fibrillation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Ear and labyrinth disorders                     
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Eye disorders                     
Conjunctival haemorrhage  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Eye irritation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Ocular hyperaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders                     
Abdominal distension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Constipation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 3/11 (27.27%)  3 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Dyspepsia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Food poisoning  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Gastritis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Gastrooesophageal reflux disease  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Inguinal hernia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2 3/11 (27.27%)  3 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
General disorders                     
Chest discomfort  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Chills  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Fatigue  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 5/11 (45.45%)  11 6/10 (60.00%)  10 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 1/9 (11.11%)  2
Feeling hot  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  4 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Feeling jittery  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site erythema  1  0/3 (0.00%)  0 2/3 (66.67%)  3 0/10 (0.00%)  0 8/11 (72.73%)  19 6/10 (60.00%)  17 0/1 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  3 6/9 (66.67%)  11 3/9 (33.33%)  6
Injection site haematoma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Injection site induration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 8/11 (72.73%)  21 9/10 (90.00%)  38 1/1 (100.00%)  1 1/2 (50.00%)  1 3/7 (42.86%)  7 5/9 (55.56%)  12 7/9 (77.78%)  14
Injection site paraesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site reaction  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site scab  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site scar  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Injection site swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 8/11 (72.73%)  13 6/10 (60.00%)  6 0/1 (0.00%)  0 0/2 (0.00%)  0 2/7 (28.57%)  2 4/9 (44.44%)  6 2/9 (22.22%)  2
Nodule  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Oedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Oedema peripheral  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  3 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Injection site mass  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Hepatobiliary disorders                     
Hyperbilirubinaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations                     
Bronchitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Celllulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Ear lobe infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Herpes zoster  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Influenza  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Lobar pneumonia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Nasopharyngitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 4/10 (40.00%)  5 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Respiratory tract infection viral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Sinusitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Skin infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Upper respiratory tract infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Injury, poisoning and procedural complications                     
Arthropod sting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Contusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Mountain sickness acute  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Investigations                     
Blood alkaline phosphatase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood amylase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood creatinine increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood lactic acid increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Blood magnesium decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood potassium increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood urine  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Blood urine present  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Glomerular filtration rate increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Lipase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Lymphocyte count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Platelet count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Protein total increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
White blood cell count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
White blood cells urine  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
White blood cells urine positive  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Metabolism and nutrition disorders                     
Decreased appetite  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Hyperglycaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Hyponatraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  3 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Back pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/10 (20.00%)  2 2/11 (18.18%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Flank pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Groin pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Muscular weakness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Myalgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  3 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Neck pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Soft tissue disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Joint swelling  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Basal cell carcinoma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders                     
Dizziness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  3 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Neuralgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Neuropathy peripheral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Paraesthesia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Peroneal nerve palsy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Presyncope  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Psychiatric disorders                     
Anxiety  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Insomnia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Renal and urinary disorders                     
Haematuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Cough  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  1 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Dyspnoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
Dyspnoea exertional  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Nasal congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Oropharyngeal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Pulmonary embolism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Rhinorrhoea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Sinus congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Upper respiratory tract congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Aspiration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Acne  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Alopecia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Hirsutism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Hyperhidrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Onychoclasis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Rash  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/9 (22.22%)  2
Rash erythematous  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Pruritus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
Vascular disorders                     
Hot flush  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & 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: NCT00753415    
Other Study ID Numbers: V934-002
2008_541 ( Other Identifier: Merck Registration Number (Telerx #) )
First Submitted: September 15, 2008
First Posted: September 16, 2008
Results First Submitted: March 19, 2014
Results First Posted: June 3, 2014
Last Update Posted: March 17, 2015