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Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

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ClinicalTrials.gov Identifier: NCT00320398
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : December 21, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition Thrombosis, Venous
Intervention Drug: Fondaparinux
Enrollment 114
Recruitment Details A total of 115 participants who had undergone total Hip replacement surgery were randomized to the study. The study was conducted from 30 January 2006 to 18 July 2006 at eight centers in Japan. A total of 114 and 94 participants were included in Safety and Full analysis set population respectively.
Pre-assignment Details  
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description Eligible participants in this arm received fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Period Title: Overall Study
Started 58 56
Completed 56 52
Not Completed 2 4
Reason Not Completed
Adverse Event             1             4
Other             1             0
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg Total
Hide Arm/Group Description Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). Total of all reporting groups
Overall Number of Baseline Participants 58 56 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>=20 years Number Analyzed 58 participants 56 participants 114 participants
58
 100.0%
56
 100.0%
114
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 56 participants 114 participants
Female
51
  87.9%
51
  91.1%
102
  89.5%
Male
7
  12.1%
5
   8.9%
12
  10.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 58 participants 56 participants 114 participants
58
 100.0%
56
 100.0%
114
 100.0%
1.Primary Outcome
Title Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period
Hide Description The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consisted of all participants who were randomized to either treatment with the exception of: those who did not receive study drug at all; and those with no valid post-randomization efficacy data (e.g., no evaluable venogram).
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(2.3 to 20.0)
2.2
(0.1 to 11.5)
2.Primary Outcome
Title Percentage of Participants With Major Bleeding
Hide Description Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall > = 2 gram per deciliter (g/dL)(1.6 millimole per litre [mmol/L]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from >= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all participants who received at least one dose of randomized study drug.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 6.2)
0
(0.0 to 6.4)
3.Secondary Outcome
Title Percentage of Participants With Minor Bleeding
Hide Description Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ [eye, adrenal gland, pericardium, spine]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall > = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from >= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2), and which were considered more than expected in the clinical context. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.7
(0.0 to 9.2)
3.6
(0.4 to 12.3)
4.Secondary Outcome
Title Percentage of Participants With All Deep Vein Thrombosis (DVT)
Hide Description The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Patients (EEP) included subpopulation of safety participants judged to be evaluable for all DVT, proximal DVT or distal only DVT by site of occurrence (total/ side of operation/ opposite side of operation/ both sides). Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: percentage of participants
8.3 2.2
5.Secondary Outcome
Title Percentage of Participants With Proximal DVT
Hide Description The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
EEP population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: percentage of participants
0 0
6.Secondary Outcome
Title Percentage of Participants With Distal Only DVT
Hide Description The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
EEP population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: percentage participants
4 1
7.Secondary Outcome
Title Percentage of Participants With Symptomatic DVT During Main Efficacy Period
Hide Description The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Percentage of Participants With Pulmonary Embolism During Efficacy Period
Hide Description The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: percentage of participants
0 0
9.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Hide Description An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Time Frame From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: participants
Deaths 0 0
Any SAE 0 0
Any AE 49 45
10.Secondary Outcome
Title Number of Transfused Participants
Hide Description The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported.
Time Frame Up to Day 17.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: participants
5 2
11.Secondary Outcome
Title Volume of Transfusion
Hide Description The total volume of transfusion (RBCs or WB) received by the participant was reported.
Time Frame Up to Day 17
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description:
Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
Overall Number of Participants Analyzed 58 56
Mean (Standard Deviation)
Unit of Measure: mL
400.0  (0.0) 600.0  (282.8)
Time Frame From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.
Adverse Event Reporting Description Safety population was used.
 
Arm/Group Title Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Hide Arm/Group Description Eligible participants in this arm received Fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). Eligible participants in this arm received Fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
All-Cause Mortality
Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/56 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Fondaparinux 1.5 mg Fondaparinux 2.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   49/58 (84.48%)   45/56 (80.36%) 
Gastrointestinal disorders     
Constipation  1  5/58 (8.62%)  10/56 (17.86%) 
Haemorrhoids  1  1/58 (1.72%)  2/56 (3.57%) 
Abdominal pain upper  1  5/58 (8.62%)  1/56 (1.79%) 
Diarrhoea  1  3/58 (5.17%)  0/56 (0.00%) 
Nausea  1  3/58 (5.17%)  0/56 (0.00%) 
General disorders     
Pyrexia  1  3/58 (5.17%)  0/56 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  2/58 (3.45%)  2/56 (3.57%) 
Investigations     
Platelet count increased  1  7/58 (12.07%)  5/56 (8.93%) 
Gamma glutamyl transferase increased  1  1/58 (1.72%)  3/56 (5.36%) 
Blood alkaline phosphatase increased  1  2/58 (3.45%)  2/56 (3.57%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  12/58 (20.69%)  14/56 (25.00%) 
Pain in extremity  1  1/58 (1.72%)  4/56 (7.14%) 
Back pain  1  6/58 (10.34%)  0/56 (0.00%) 
Nervous system disorders     
Headache  1  5/58 (8.62%)  2/56 (3.57%) 
Dizziness  1  3/58 (5.17%)  2/56 (3.57%) 
Psychiatric disorders     
Insomnia  1  9/58 (15.52%)  13/56 (23.21%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  3/58 (5.17%)  9/56 (16.07%) 
Dermatitis contact  1  2/58 (3.45%)  2/56 (3.57%) 
Erythema  1  2/58 (3.45%)  2/56 (3.57%) 
Rash  1  1/58 (1.72%)  2/56 (3.57%) 
Urticaria  1  0/58 (0.00%)  2/56 (3.57%) 
1
Term from vocabulary, MedDRA Ver. 9.0
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00320398     History of Changes
Other Study ID Numbers: AR3106333
First Submitted: May 1, 2006
First Posted: May 3, 2006
Results First Submitted: May 12, 2017
Results First Posted: December 21, 2017
Last Update Posted: September 3, 2018