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Late-Onset Treatment Study Extension Protocol

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ClinicalTrials.gov Identifier: NCT00455195
Recruitment Status : Completed
First Posted : April 3, 2007
Results First Posted : January 5, 2012
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pompe Disease (Late-Onset)
Glycogen Storage Disease Type II (GSD-II)
Glycogenesis Type II
Acid Maltase Deficiency (AMD)
Intervention Biological: alglucosidase alfa
Enrollment 81
Recruitment Details  
Pre-assignment Details 81 of the 90 participants enrolled in the double-blind placebo controlled AGLU02704 (NCT00158600) study continued on to the open-label extension study AGLU03206.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa
Hide Arm/Group Description Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206. Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
Period Title: Double-blind Study AGLU02704
Started 60 [1] 30 [2]
Completed 55 26
Not Completed 5 4
Reason Not Completed
Adverse Event             2             1
Death             1             0
Withdrawal by Subject             2             2
Unable to commit time to study             0             1
[1]
Patients randomized to alglucosidase alfa treatment group in AGLU02704 (NCT00158600).
[2]
See study AGLU02704 (NCT00158600) for results while on placebo.
Period Title: Extension Study AGLU03206
Started 55 26 [1]
Completed 55 26
Not Completed 0 0
[1]
These 26 participants completed placebo double-blind treatment in the AGLU02704 (NCT00158600) study.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa Total
Hide Arm/Group Description Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206. Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented. Total of all reporting groups
Overall Number of Baseline Participants 60 26 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 26 participants 86 participants
45.3  (12.37) 46.8  (8.62) 45.73  (11.34)
[1]
Measure Description: Age at first infusion of alglucosidase alfa. The Alglucosidase Alfa/Alglucosidase Alfa treatment arm includes participants' study experience in the double-blind study (AGLU02704 (NCT00158600)) and the extension study (AGLU03206 (NCT00455195) hence 60 participants are represented. The Placebo/Alglucosidase Alfa treatment arm includes participants' study experience on Alglucosidase Alfa in the extension study (AGLU03206) hence 26 participants are represented.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 26 participants 86 participants
Female
26
  43.3%
15
  57.7%
41
  47.7%
Male
34
  56.7%
11
  42.3%
45
  52.3%
[1]
Measure Description: The Alglucosidase Alfa/Alglucosidase Alfa treatment arm includes participants' study experience in the double-blind study (AGLU02704 (NCT00158600)) and the extension study (AGLU03206 (NCT00455195) hence 60 participants are represented. The Placebo/Alglucosidase Alfa treatment arm includes participants' study experience on Alglucosidase Alfa in the extension study (AGLU03206) hence 26 participants are represented.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 26 participants 86 participants
Hispanic 1 1 2
Asian 1 0 1
Black or African American 0 0 0
White 57 24 81
Unknown or Not Reported 1 1 2
[1]
Measure Description: The Alglucosidase Alfa/Alglucosidase Alfa treatment arm includes participants' study experience in the double-blind study (AGLU02704 (NCT00158600)) and the extension study (AGLU03206 (NCT00455195) hence 60 participants are represented. The Placebo/Alglucosidase Alfa treatment arm includes participants' study experience on Alglucosidase Alfa in the extension study (AGLU03206) hence 26 participants are represented.
1.Primary Outcome
Title Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description

The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa.

Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).

Time Frame Week 0 to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Participants with any AEs 60
Participants with Treatment-Related AEs 37
Participants with Infusion-Associated Reactions 21
Participants with Serious AEs 15
Participants with Severe AEs 16
Participants- Discontinued Due to AEs (incl death) 3
Participants Who Died 1
2.Primary Outcome
Title Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: meters
332.2  (126.69)
3.Primary Outcome
Title Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: meters
21.3  (78.02)
4.Primary Outcome
Title Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: percent of predicted FVC
55.4  (14.44)
5.Primary Outcome
Title Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: percent of predicted FVC
0.8  (6.68)
6.Secondary Outcome
Title Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: percent of predicted QMT
37.7  (18.88)
7.Secondary Outcome
Title Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: percent of predicted QMT
2.1  (11.06)
8.Secondary Outcome
Title Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.33  (8.934)
9.Secondary Outcome
Title Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)
Hide Description The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).
Time Frame Week 0 , Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa
Hide Arm/Group Description:
Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.64  (7.618)
Time Frame Adverse events for the Alglucosidase Alfa/Alglucosidase Alfa group cover up to 2.5 years (Week 0 to 2.5 years), and for the Placebo/Alglucosidase Alfa group cover up to 1.0 year (Week 78 to 2.5 years).
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
 
Arm/Group Title Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa Overall
Hide Arm/Group Description Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206. Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented. The combined alglucosidase alfa treatment experience from the two treatment groups.
All-Cause Mortality
Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/60 (25.00%)   2/26 (7.69%)   17/86 (19.77%) 
Cardiac disorders       
Coronary artery disease  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Supraventricular tachycardia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Gastrointestinal disorders       
Abdominal pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Gastric ulcer  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
General disorders       
Chest discomfort  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Non-cardiac chest pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Immune system disorders       
Hypersensitivity  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Infections and infestations       
Gastroenteritis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pneumonia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Injury, poisoning and procedural complications       
Fall  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Humerus fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Spinal compression fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Metabolism and nutrition disorders       
Dehydration  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma stage II  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Nervous system disorders       
Brain stem ischaemia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders       
Hydronephrosis  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Nephrolithiasis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Renal cyst  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders       
Lung disorder  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Throat tightness  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders       
Angioneurotic oedema  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vascular disorders       
Aneurysm  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alglucosidase Alfa/Alglucosidase Alfa Placebo/Alglucosidase Alfa Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/60 (100.00%)   25/26 (96.15%)   85/86 (98.84%) 
Blood and lymphatic system disorders       
Anaemia  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Lymphadenopathy  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Macrocytosis  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Normochromic normocytic anaemia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Spontaneous haematoma  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Cardiac disorders       
Angina pectoris  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Atrial hypertrophy  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Bundle branch block left  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Bundle branch block right  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Coronary artery disease  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Palpitations  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Sinus tachycardia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tachycardia  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Tricuspid valve incompetence  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Ventricular dysfunction  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Ventricular hypertrophy  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Ear and labyrinth disorders       
Auricular swelling  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cerumen impaction  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Ear congestion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Ear discomfort  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Ear pain  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Hypoacusis  1  23/60 (38.33%)  3/26 (11.54%)  26/86 (30.23%) 
Presbyacusis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tinnitus  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Vertigo  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Vertigo positional  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Eye disorders       
Altered visual depth perception  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Asthenopia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cataract  1  4/60 (6.67%)  1/26 (3.85%)  5/86 (5.81%) 
Conjunctivitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Diplopia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dry eye  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Eye irritation  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Eye pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Eye pruritus  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Eyelid ptosis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Keratoconjunctivitis sicca  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Photophobia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pinguecula  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Retinal detachment  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vision blurred  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Visual acuity reduced  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Visual disturbance  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vitreous floaters  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Gastrointestinal disorders       
Abdominal discomfort  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Abdominal distension  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Abdominal mass  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Abdominal pain  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Abdominal pain lower  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Abdominal pain upper  1  6/60 (10.00%)  1/26 (3.85%)  7/86 (8.14%) 
Abdominal tenderness  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Anal fissure  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Anorectal disorder  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Aphthous stomatitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Bowel sounds abnormal  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Chapped lips  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Constipation  1  7/60 (11.67%)  0/26 (0.00%)  7/86 (8.14%) 
Crohn's disease  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Diarrhoea  1  20/60 (33.33%)  2/26 (7.69%)  22/86 (25.58%) 
Diverticulum intestinal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dry mouth  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dyspepsia  1  7/60 (11.67%)  0/26 (0.00%)  7/86 (8.14%) 
Epigastric discomfort  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Flatulence  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Food poisoning  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Gastrooesophageal reflux disease  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Gingivitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Haematochezia  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Haemorrhoids  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Inguinal hernia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Lip swelling  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
Mouth ulceration  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Nausea  1  15/60 (25.00%)  2/26 (7.69%)  17/86 (19.77%) 
Oesophageal pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Oral pruritus  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Paraesthesia oral  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rectal haemorrhage  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Retching  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Stomach discomfort  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Swollen tongue  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Toothache  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vomiting  1  14/60 (23.33%)  2/26 (7.69%)  16/86 (18.60%) 
General disorders       
Adverse drug reaction  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Application site vesicles  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Asthenia  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Axillary pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Catheter related complication  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Catheter site pain  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Chest discomfort  1  7/60 (11.67%)  0/26 (0.00%)  7/86 (8.14%) 
Chest pain  1  6/60 (10.00%)  2/26 (7.69%)  8/86 (9.30%) 
Chills  1  4/60 (6.67%)  1/26 (3.85%)  5/86 (5.81%) 
Disease progression  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Fatigue  1  13/60 (21.67%)  4/26 (15.38%)  17/86 (19.77%) 
Feeling abnormal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Feeling cold  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Feeling hot  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Gait disturbance  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Influenza like illness  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Infusion site bruising  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Infusion site pain  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Infusion site paraesthesia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Infusion site reaction  1  7/60 (11.67%)  0/26 (0.00%)  7/86 (8.14%) 
Injection site pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Injection site phlebitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Local swelling  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Malaise  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Nodule  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Oedema peripheral  1  13/60 (21.67%)  1/26 (3.85%)  14/86 (16.28%) 
Pain  1  6/60 (10.00%)  0/26 (0.00%)  6/86 (6.98%) 
Pitting oedema  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Puncture site haemorrhage  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pyrexia  1  12/60 (20.00%)  2/26 (7.69%)  14/86 (16.28%) 
Thirst  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Immune system disorders       
Hypersensitivity  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
Seasonal allergy  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Infections and infestations       
Acute tonsillitis  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Bronchiolitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Bronchitis  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Bronchitis acute  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cellulitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cystitis  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Dermatophytosis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Ear infection  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Eye infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Folliculitis  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Fungal infection  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Fungal skin infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Gastroenteritis  1  8/60 (13.33%)  0/26 (0.00%)  8/86 (9.30%) 
Gastroenteritis viral  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Gingival infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Herpes simplex  1  4/60 (6.67%)  1/26 (3.85%)  5/86 (5.81%) 
Herpes virus infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Herpes zoster  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Influenza  1  8/60 (13.33%)  3/26 (11.54%)  11/86 (12.79%) 
Kidney infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Laryngitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Localised infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Lower respiratory tract infection  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Mucosal infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Nasopharyngitis  1  29/60 (48.33%)  8/26 (30.77%)  37/86 (43.02%) 
Otitis media  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pharyngitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pharyngitis streptococcal  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Pneumonia  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Postoperative wound infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rash pustular  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Respiratory tract infection  1  3/60 (5.00%)  1/26 (3.85%)  4/86 (4.65%) 
Rhinitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Sinusitis  1  9/60 (15.00%)  3/26 (11.54%)  12/86 (13.95%) 
Tinea pedis  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Tonsillitis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tooth abscess  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tooth infection  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Upper respiratory tract infection  1  20/60 (33.33%)  6/26 (23.08%)  26/86 (30.23%) 
Urinary tract infection  1  5/60 (8.33%)  2/26 (7.69%)  7/86 (8.14%) 
Urinary tract infection bacterial  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Vaginal infection  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Viral infection  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Wound infection  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Injury, poisoning and procedural complications       
Animal bite  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Animal scratch  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Arthropod bite  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Arthropod sting  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Back injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Concussion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Contusion  1  9/60 (15.00%)  1/26 (3.85%)  10/86 (11.63%) 
Excoriation  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Fall  1  39/60 (65.00%)  13/26 (50.00%)  52/86 (60.47%) 
Femur fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Foot fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Head injury  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Humerus fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Injury  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Injury corneal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Joint sprain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Ligament injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Limb crushing injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Limb injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Mouth injury  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Muscle strain  1  6/60 (10.00%)  2/26 (7.69%)  8/86 (9.30%) 
Neck injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pelvic fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Post-traumatic pain  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Procedural pain  1  9/60 (15.00%)  1/26 (3.85%)  10/86 (11.63%) 
Radial nerve injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rib fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Road traffic accident  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Scratch  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Skin laceration  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Soft tissue injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tendon injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tendon rupture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Thermal burn  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Tooth fracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tooth injury  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Traumatic ulcer  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vaccination complication  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Wound  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Investigations       
Alanine aminotransferase increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Aspartate aminotransferase increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Blood creatine increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Blood folate decreased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Blood glucose increased  1  1/60 (1.67%)  2/26 (7.69%)  3/86 (3.49%) 
Blood pressure increased  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Blood uric acid increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Blood urine present  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Body temperature increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Carbon dioxide increased  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Crystal urine present  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Electrocardiogram QT corrected interval prolonged  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Electrocardiogram ST segment depression  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Electrocardiogram T wave amplitude decreased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Electrocardiogram abnormal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Fungus urine test positive  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Glucose urine present  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Haematocrit decreased  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Neutrophil count increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Oxygen saturation decreased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Protein urine present  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Specific gravity urine increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tandem gait test abnormal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Urine analysis abnormal  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Urine ketone body present  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Weight decreased  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
White blood cell count increased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
White blood cells urine positive  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Metabolism and nutrition disorders       
Anorexia  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Decreased appetite  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Gout  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hyperglycaemia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hypernatraemia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hypertriglyceridaemia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hypokalaemia  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  25/60 (41.67%)  4/26 (15.38%)  29/86 (33.72%) 
Arthritis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Back pain  1  19/60 (31.67%)  6/26 (23.08%)  25/86 (29.07%) 
Bone pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Bursitis  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Buttock pain  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Costochondritis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Flank pain  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Groin pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Joint contracture  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Joint crepitation  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Muscle atrophy  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Muscle contracture  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Muscle spasms  1  17/60 (28.33%)  5/26 (19.23%)  22/86 (25.58%) 
Muscle tightness  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Muscle twitching  1  6/60 (10.00%)  0/26 (0.00%)  6/86 (6.98%) 
Muscular weakness  1  11/60 (18.33%)  2/26 (7.69%)  13/86 (15.12%) 
Musculoskeletal chest pain  1  6/60 (10.00%)  1/26 (3.85%)  7/86 (8.14%) 
Musculoskeletal discomfort  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Musculoskeletal disorder  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Musculoskeletal pain  1  10/60 (16.67%)  4/26 (15.38%)  14/86 (16.28%) 
Musculoskeletal stiffness  1  8/60 (13.33%)  0/26 (0.00%)  8/86 (9.30%) 
Myalgia  1  16/60 (26.67%)  3/26 (11.54%)  19/86 (22.09%) 
Neck pain  1  9/60 (15.00%)  1/26 (3.85%)  10/86 (11.63%) 
Nose deformity  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Osteoarthritis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Osteopenia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Osteoporosis  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Pain in extremity  1  23/60 (38.33%)  2/26 (7.69%)  25/86 (29.07%) 
Senile ankylosing vertebral hyperostosis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Sensation of heaviness  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Temporomandibular joint syndrome  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tendonitis  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
Tenosynovitis stenosans  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin papilloma  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Nervous system disorders       
Areflexia  1  5/60 (8.33%)  2/26 (7.69%)  7/86 (8.14%) 
Balance disorder  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Burning sensation  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Carpal tunnel syndrome  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dizziness  1  16/60 (26.67%)  3/26 (11.54%)  19/86 (22.09%) 
Dizziness postural  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Facial palsy  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Headache  1  31/60 (51.67%)  6/26 (23.08%)  37/86 (43.02%) 
Hyperreflexia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hypoaesthesia  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Hyporeflexia  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Intercostal neuralgia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Lethargy  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
Loss of consciousness  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Migraine  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Nerve compression  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Neuralgia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Paraesthesia  1  7/60 (11.67%)  0/26 (0.00%)  7/86 (8.14%) 
Sciatica  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Sensory disturbance  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Sinus headache  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Somnolence  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Syncope vasovagal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Tremor  1  4/60 (6.67%)  1/26 (3.85%)  5/86 (5.81%) 
Psychiatric disorders       
Anger  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Anxiety  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Depression  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Insomnia  1  9/60 (15.00%)  0/26 (0.00%)  9/86 (10.47%) 
Post-traumatic stress disorder  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Stress  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders       
Dysuria  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Haematuria  1  3/60 (5.00%)  1/26 (3.85%)  4/86 (4.65%) 
Leukocyturia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Nephrolithiasis  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Pollakiuria  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Proteinuria  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Pyuria  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Renal cyst  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Urge incontinence  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Urinary incontinence  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Urine flow decreased  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Urine odour abnormal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Reproductive system and breast disorders       
Breast pain  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Breast swelling  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Breast tenderness  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dysmenorrhoea  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Fibrocystic breast disease  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Menorrhagia  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Menstrual discomfort  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Menstruation irregular  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Pelvic pain  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Vaginal haemorrhage  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders       
Bronchospasm  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Choking  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Cough  1  8/60 (13.33%)  5/26 (19.23%)  13/86 (15.12%) 
Dyspnoea  1  9/60 (15.00%)  1/26 (3.85%)  10/86 (11.63%) 
Dyspnoea exertional  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Epistaxis  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Increased bronchial secretion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Lung disorder  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Lung infiltration  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Nasal congestion  1  8/60 (13.33%)  0/26 (0.00%)  8/86 (9.30%) 
Pharyngolaryngeal pain  1  14/60 (23.33%)  3/26 (11.54%)  17/86 (19.77%) 
Postnasal drip  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Respiratory distress  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Respiratory failure  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Respiratory tract congestion  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Rhinorrhoea  1  3/60 (5.00%)  1/26 (3.85%)  4/86 (4.65%) 
Sinus congestion  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Sleep apnoea syndrome  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Sneezing  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Throat irritation  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Throat tightness  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Upper respiratory tract congestion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Wheezing  1  1/60 (1.67%)  1/26 (3.85%)  2/86 (2.33%) 
Skin and subcutaneous tissue disorders       
Actinic keratosis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cold sweat  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Decubitus ulcer  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dermatitis contact  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Dry skin  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Ecchymosis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Erythema  1  3/60 (5.00%)  0/26 (0.00%)  3/86 (3.49%) 
Heat rash  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Hyperhidrosis  1  6/60 (10.00%)  1/26 (3.85%)  7/86 (8.14%) 
Ingrowing nail  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Night sweats  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Photosensitivity reaction  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Pruritus  1  8/60 (13.33%)  3/26 (11.54%)  11/86 (12.79%) 
Psoriasis  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rash  1  9/60 (15.00%)  1/26 (3.85%)  10/86 (11.63%) 
Rash macular  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rash maculo-papular  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Rash papular  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Rash pruritic  1  4/60 (6.67%)  0/26 (0.00%)  4/86 (4.65%) 
Rosacea  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin hyperpigmentation  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin inflammation  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Skin lesion  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin nodule  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Skin odour abnormal  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Subcutaneous nodule  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Urticaria  1  7/60 (11.67%)  1/26 (3.85%)  8/86 (9.30%) 
Urticaria contact  1  0/60 (0.00%)  1/26 (3.85%)  1/86 (1.16%) 
Vascular disorders       
Aneurysm  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Cardiovascular insufficiency  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Diastolic hypotension  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Flushing  1  3/60 (5.00%)  1/26 (3.85%)  4/86 (4.65%) 
Haematoma  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Hot flush  1  2/60 (3.33%)  0/26 (0.00%)  2/86 (2.33%) 
Hypertension  1  5/60 (8.33%)  0/26 (0.00%)  5/86 (5.81%) 
Hypotension  1  2/60 (3.33%)  1/26 (3.85%)  3/86 (3.49%) 
Raynaud's phenomenon  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Vasoconstriction  1  1/60 (1.67%)  0/26 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00455195     History of Changes
Other Study ID Numbers: AGLU03206
2006-003644-31 ( EudraCT Number )
First Submitted: March 30, 2007
First Posted: April 3, 2007
Results First Submitted: November 23, 2011
Results First Posted: January 5, 2012
Last Update Posted: March 7, 2014