A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT01526785
Collaborator
(none)
113
51
1
33
2.2
0.1
Study Details
Study Description
Brief Summary
The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
113 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 4 Open Label, Prospective Study in Patients With Pompe Disease to Evaluate The Efficacy and Safety of Alglucosidase Alfa Produced at the 4000L Scale
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alglucosidase alfa Alglucosidase alfa (4000 L scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice. |
Drug: Alglucosidase alfa
4000 L alglucosidase alfa administered by IV infusion at the same dose and dose regimen used for the patient's routine treatment prior to the study for 52 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Were Clinically Stable or Improved at Week 52 [Week 52]
Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.
Secondary Outcome Measures
- Survival Rate at Week 52 [Week 52]
Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.
- Invasive Ventilator-Free Survival Rate at Week 52 [Week 52]
Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.
- Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52 [Baseline, Week 52]
Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.
- Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52 [Baseline, Week 52]
GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.
- Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position [Baseline, Week 52]
Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. 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%.
- Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position [Baseline, Week 52]
Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. 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%.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
A participant might meet all of the following criteria to be eligible for this study.
-
The participant and/or their parent/legal guardian was willing and able to provide signed informed consent.
-
The participant might be at least 1 year of age at the time of informed consent.
-
The participant had a diagnosis of Pompe disease and might have received treatment with 160 L alglucosidase alfa prior to screening.
-
The participant, if female and of childbearing potential, might have a negative pregnancy test (urine beta-human chorionic gonadotropin) at baseline. Note: all female participants of childbearing potential and sexually mature males might agree to use a medically accepted method of contraception throughout the study.
Exclusion Criteria:
A participant who met any of the following criteria were to be excluded from this study.
-
The participant had within the past 3 months received or was currently receiving any investigational product other than 160 L alglucosidase alfa or was currently participating in another clinical treatment study.
-
The participant, in the opinion of the Investigator, was clinically unstable and would not be expected to survive to completion of the 52-week treatment period.
-
The participant and/or their parent/legal guardian, in the opinion of the Investigator, was unable to adhere to the requirements of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Phoenix | Arizona | United States | ||
| 3 | Little Rock | Arkansas | United States | ||
| 4 | Oakland | California | United States | ||
| 5 | Orange | California | United States | ||
| 6 | San Diego | California | United States | ||
| 7 | San Jose | California | United States | ||
| 8 | Stanford | California | United States | ||
| 9 | Aurora | Colorado | United States | ||
| 10 | Washington, DC | District of Columbia | United States | ||
| 11 | Gainesville | Florida | United States | ||
| 12 | Miami | Florida | United States | ||
| 13 | Decatur | Georgia | United States | ||
| 14 | Chicago | Illinois | United States | ||
| 15 | Indianapolis | Indiana | United States | ||
| 16 | Kansas City | Kansas | United States | ||
| 17 | Louisville | Kentucky | United States | ||
| 18 | Baton Rouge | Louisiana | United States | ||
| 19 | Shreveport | Louisiana | United States | ||
| 20 | Boston | Massachusetts | United States | ||
| 21 | Detroit | Michigan | United States | ||
| 22 | Grand Rapids | Michigan | United States | ||
| 23 | Minneapolis | Minnesota | United States | ||
| 24 | Jackson | Mississippi | United States | ||
| 25 | Columbia | Missouri | United States | ||
| 26 | Kansas City | Missouri | United States | ||
| 27 | St. Louis | Missouri | United States | ||
| 28 | Omaha | Nebraska | United States | ||
| 29 | Las Vegas | Nevada | United States | ||
| 30 | New Brunswick | New Jersey | United States | ||
| 31 | Glens Falls | New York | United States | ||
| 32 | New York | New York | United States | ||
| 33 | Rochester | New York | United States | ||
| 34 | Syracuse | New York | United States | ||
| 35 | Valhalla | New York | United States | ||
| 36 | Asheville | North Carolina | United States | ||
| 37 | Durham | North Carolina | United States | ||
| 38 | Cincinnati | Ohio | United States | ||
| 39 | Cleveland | Ohio | United States | ||
| 40 | Philadelphia | Pennsylvania | United States | ||
| 41 | Pittsburgh | Pennsylvania | United States | ||
| 42 | Providence | Rhode Island | United States | ||
| 43 | Memphis | Tennessee | United States | ||
| 44 | Nashville | Tennessee | United States | ||
| 45 | Austin | Texas | United States | ||
| 46 | Fort Worth | Texas | United States | ||
| 47 | Salt Lake City | Utah | United States | ||
| 48 | Norfolk | Virginia | United States | ||
| 49 | Seattle | Washington | United States | ||
| 50 | Morgantown | West Virginia | United States | ||
| 51 | Miliwaukee | Wisconsin | United States |
Sponsors and Collaborators
- Genzyme, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Genzyme, a Sanofi Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01526785
Other Study ID Numbers:
- AGLU09411
- EFC12720
First Posted:
Feb 6, 2012
Last Update Posted:
Dec 8, 2015
Last Verified:
Nov 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The study was conducted in the United States. A total of 113 participants were treated between 9 March 2012 and 4 June 2014. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice. |
| Period Title: Overall Study | |
| STARTED | 113 |
| COMPLETED | 100 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Overall Participants | 113 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
4.8
(3.73)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
53
46.9%
|
| Male |
60
53.1%
|
Outcome Measures
| Title | Percentage of Participants Who Were Clinically Stable or Improved at Week 52 |
|---|---|
| Description | Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 104 |
| Number (95% Confidence Interval) [percentage of participants] |
83.7
74.1%
|
| Title | Survival Rate at Week 52 |
|---|---|
| Description | Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 113 |
| Number (95% Confidence Interval) [percentage of participants] |
98.1
86.8%
|
| Title | Invasive Ventilator-Free Survival Rate at Week 52 |
|---|---|
| Description | Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 81 |
| Number (95% Confidence Interval) [percentage of participants] |
92.4
81.8%
|
| Title | Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52 |
|---|---|
| Description | Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. |
| Time Frame | Baseline, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 67 |
| Mean (Standard Deviation) [Z score] |
-0.5
(1.71)
|
| Title | Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52 |
|---|---|
| Description | GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions. |
| Time Frame | Baseline, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 90 |
| Mean (Standard Deviation) [percentage of total score] |
3.7
(17.46)
|
| Title | Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position |
|---|---|
| Description | Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. 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 Frame | Baseline, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [percent predicted FVC] |
3.2
(11.07)
|
| Title | Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position |
|---|---|
| Description | Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. 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 Frame | Baseline, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data. |
| Arm/Group Title | Alglucosidase Alfa |
|---|---|
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice. |
| Measure Participants | 22 |
| Mean (Standard Deviation) [percent predicted FVC] |
2.3
(11.8)
|
Adverse Events
| Time Frame | All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. | |
|---|---|---|
| Adverse Event Reporting Description | Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated participants. | |
| Arm/Group Title | Alglucosidase Alfa | |
| Arm/Group Description | Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice. | |
All Cause Mortality |
||
| Alglucosidase Alfa | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Alglucosidase Alfa | ||
| Affected / at Risk (%) | # Events | |
| Total | 73/113 (64.6%) | |
| Cardiac disorders | ||
| Bradycardia | 2/113 (1.8%) | |
| Cardiac arrest | 1/113 (0.9%) | |
| Cardiac failure congestive | 1/113 (0.9%) | |
| Cardio-respiratory arrest | 3/113 (2.7%) | |
| Cardiopulmonary failure | 1/113 (0.9%) | |
| Cyanosis | 1/113 (0.9%) | |
| Left ventricular hypertrophy | 2/113 (1.8%) | |
| Mitral valve incompetence | 1/113 (0.9%) | |
| Pulseless electrical activity | 1/113 (0.9%) | |
| Sinus tachycardia | 1/113 (0.9%) | |
| Supraventricular tachycardia | 4/113 (3.5%) | |
| Tachycardia | 1/113 (0.9%) | |
| Ear and labyrinth disorders | ||
| Motion sickness | 1/113 (0.9%) | |
| Eye disorders | ||
| Eyelid ptosis | 1/113 (0.9%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 2/113 (1.8%) | |
| Constipation | 2/113 (1.8%) | |
| Dental caries | 1/113 (0.9%) | |
| Diarrhoea | 1/113 (0.9%) | |
| Dysphagia | 1/113 (0.9%) | |
| Gastrointestinal disorder | 1/113 (0.9%) | |
| Gastrooesophageal reflux disease | 1/113 (0.9%) | |
| Intussusception | 1/113 (0.9%) | |
| Nausea | 1/113 (0.9%) | |
| Vomiting | 2/113 (1.8%) | |
| General disorders | ||
| Chest pain | 2/113 (1.8%) | |
| Chills | 2/113 (1.8%) | |
| Device breakage | 1/113 (0.9%) | |
| Device malfunction | 1/113 (0.9%) | |
| Hypothermia | 1/113 (0.9%) | |
| Oedema peripheral | 1/113 (0.9%) | |
| Pyrexia | 10/113 (8.8%) | |
| Hepatobiliary disorders | ||
| Cholecystitis acute | 1/113 (0.9%) | |
| Infections and infestations | ||
| Adenovirus infection | 1/113 (0.9%) | |
| Bacteraemia | 2/113 (1.8%) | |
| Bacterial tracheitis | 2/113 (1.8%) | |
| Bronchiolitis | 2/113 (1.8%) | |
| Cellulitis | 1/113 (0.9%) | |
| Device related infection | 6/113 (5.3%) | |
| Gastroenteritis | 1/113 (0.9%) | |
| Gastroenteritis viral | 3/113 (2.7%) | |
| Haemophilus bacteraemia | 1/113 (0.9%) | |
| Influenza | 2/113 (1.8%) | |
| Klebsiella bacteraemia | 1/113 (0.9%) | |
| Lobar pneumonia | 1/113 (0.9%) | |
| Lung infection | 1/113 (0.9%) | |
| Metapneumovirus infection | 3/113 (2.7%) | |
| Otitis media acute | 1/113 (0.9%) | |
| Parainfluenzae virus infection | 1/113 (0.9%) | |
| Periumbilical abscess | 1/113 (0.9%) | |
| Pneumonia | 25/113 (22.1%) | |
| Pneumonia parainfluenzae viral | 1/113 (0.9%) | |
| Pneumonia pseudomonal | 1/113 (0.9%) | |
| Pneumonia respiratory syncytial viral | 2/113 (1.8%) | |
| Pneumonia viral | 3/113 (2.7%) | |
| Respiratory syncytial virus bronchiolitis | 1/113 (0.9%) | |
| Respiratory syncytial virus infection | 1/113 (0.9%) | |
| Respiratory tract infection | 4/113 (3.5%) | |
| Respiratory tract infection viral | 1/113 (0.9%) | |
| Rhinovirus infection | 3/113 (2.7%) | |
| Sepsis | 2/113 (1.8%) | |
| Staphylococcal infection | 1/113 (0.9%) | |
| Tracheitis | 5/113 (4.4%) | |
| Tracheostomy infection | 1/113 (0.9%) | |
| Upper respiratory tract infection | 2/113 (1.8%) | |
| Urinary tract infection | 3/113 (2.7%) | |
| Urinary tract infection bacterial | 1/113 (0.9%) | |
| Urinary tract infection staphylococcal | 1/113 (0.9%) | |
| Urosepsis | 1/113 (0.9%) | |
| Viral infection | 2/113 (1.8%) | |
| Injury, poisoning and procedural complications | ||
| Feeding tube complication | 1/113 (0.9%) | |
| Femur fracture | 1/113 (0.9%) | |
| Foreign body | 1/113 (0.9%) | |
| Foreign body aspiration | 1/113 (0.9%) | |
| Tracheal obstruction | 1/113 (0.9%) | |
| Traumatic haemothorax | 1/113 (0.9%) | |
| Investigations | ||
| Alanine aminotransferase increased | 1/113 (0.9%) | |
| Aspartate aminotransferase increased | 1/113 (0.9%) | |
| Blood albumin decreased | 1/113 (0.9%) | |
| Gamma-glutamyltransferase increased | 1/113 (0.9%) | |
| Oxygen saturation decreased | 3/113 (2.7%) | |
| Metabolism and nutrition disorders | ||
| Dehydration | 3/113 (2.7%) | |
| Failure to thrive | 1/113 (0.9%) | |
| Fluid overload | 1/113 (0.9%) | |
| Hypoglycaemia | 1/113 (0.9%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscle contracture | 1/113 (0.9%) | |
| Muscular weakness | 2/113 (1.8%) | |
| Nervous system disorders | ||
| Brain injury | 1/113 (0.9%) | |
| Cerebral ischaemia | 1/113 (0.9%) | |
| Convulsion | 2/113 (1.8%) | |
| Gross motor delay | 1/113 (0.9%) | |
| Loss of consciousness | 1/113 (0.9%) | |
| Presyncope | 1/113 (0.9%) | |
| Tremor | 1/113 (0.9%) | |
| Psychiatric disorders | ||
| Mental status changes | 1/113 (0.9%) | |
| Self-injurious ideation | 1/113 (0.9%) | |
| Renal and urinary disorders | ||
| Urinary retention | 3/113 (2.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory distress syndrome | 2/113 (1.8%) | |
| Acute respiratory failure | 2/113 (1.8%) | |
| Apnoea | 1/113 (0.9%) | |
| Aspiration | 1/113 (0.9%) | |
| Atelectasis | 3/113 (2.7%) | |
| Bronchial secretion retention | 1/113 (0.9%) | |
| Bronchiectasis | 2/113 (1.8%) | |
| Chronic respiratory failure | 1/113 (0.9%) | |
| Cough | 2/113 (1.8%) | |
| Dyspnoea | 5/113 (4.4%) | |
| Hypoxia | 3/113 (2.7%) | |
| Pneumonia aspiration | 4/113 (3.5%) | |
| Pneumothorax | 1/113 (0.9%) | |
| Pulmonary granuloma | 1/113 (0.9%) | |
| Respiratory disorder | 1/113 (0.9%) | |
| Respiratory distress | 16/113 (14.2%) | |
| Respiratory failure | 7/113 (6.2%) | |
| Respiratory tract congestion | 1/113 (0.9%) | |
| Rhonchi | 1/113 (0.9%) | |
| Skin and subcutaneous tissue disorders | ||
| Hyperhidrosis | 1/113 (0.9%) | |
| Purpura | 1/113 (0.9%) | |
| Rash | 1/113 (0.9%) | |
| Surgical and medical procedures | ||
| Central venous catheterisation | 1/113 (0.9%) | |
| Therapeutic procedure | 1/113 (0.9%) | |
| Vascular disorders | ||
| Hypotension | 1/113 (0.9%) | |
| Jugular vein thrombosis | 1/113 (0.9%) | |
Other (Not Including Serious) Adverse Events |
||
| Alglucosidase Alfa | ||
| Affected / at Risk (%) | # Events | |
| Total | 113/113 (100%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 7/113 (6.2%) | |
| Coagulopathy | 1/113 (0.9%) | |
| Eosinophilia | 6/113 (5.3%) | |
| Iron deficiency anaemia | 2/113 (1.8%) | |
| Lymphadenitis | 1/113 (0.9%) | |
| Lymphadenopathy | 1/113 (0.9%) | |
| Neutropenia | 1/113 (0.9%) | |
| Cardiac disorders | ||
| Arrhythmia | 3/113 (2.7%) | |
| Bradycardia | 2/113 (1.8%) | |
| Bundle branch block right | 1/113 (0.9%) | |
| Cardiac failure | 2/113 (1.8%) | |
| Cardiomyopathy | 1/113 (0.9%) | |
| Defect conduction intraventricular | 4/113 (3.5%) | |
| Diastolic dysfunction | 1/113 (0.9%) | |
| Heart valve incompetence | 1/113 (0.9%) | |
| Left ventricular dysfunction | 1/113 (0.9%) | |
| Pericardial effusion | 5/113 (4.4%) | |
| Right atrial dilatation | 1/113 (0.9%) | |
| Right ventricular hypertrophy | 1/113 (0.9%) | |
| Sinus bradycardia | 1/113 (0.9%) | |
| Sinus tachycardia | 2/113 (1.8%) | |
| Supraventricular tachycardia | 3/113 (2.7%) | |
| Tachycardia | 13/113 (11.5%) | |
| Tricuspid valve incompetence | 1/113 (0.9%) | |
| Wolff-Parkinson-White syndrome | 2/113 (1.8%) | |
| Congenital, familial and genetic disorders | ||
| Cryptorchism | 1/113 (0.9%) | |
| Ear and labyrinth disorders | ||
| Cerumen impaction | 3/113 (2.7%) | |
| Conductive deafness | 1/113 (0.9%) | |
| Deafness | 1/113 (0.9%) | |
| Deafness neurosensory | 1/113 (0.9%) | |
| Deafness unilateral | 1/113 (0.9%) | |
| Ear pain | 5/113 (4.4%) | |
| Eustachian tube dysfunction | 5/113 (4.4%) | |
| Middle ear effusion | 5/113 (4.4%) | |
| Mixed deafness | 1/113 (0.9%) | |
| Otorrhoea | 3/113 (2.7%) | |
| Tympanic membrane disorder | 1/113 (0.9%) | |
| Tympanic membrane perforation | 1/113 (0.9%) | |
| Endocrine disorders | ||
| Precocious puberty | 2/113 (1.8%) | |
| Eye disorders | ||
| Astigmatism | 2/113 (1.8%) | |
| Blepharitis | 1/113 (0.9%) | |
| Chalazion | 1/113 (0.9%) | |
| Conjunctival hyperaemia | 1/113 (0.9%) | |
| Dry eye | 4/113 (3.5%) | |
| Eye discharge | 1/113 (0.9%) | |
| Eye irritation | 1/113 (0.9%) | |
| Eye pruritus | 1/113 (0.9%) | |
| Eye swelling | 1/113 (0.9%) | |
| Eyelid oedema | 1/113 (0.9%) | |
| Eyelid ptosis | 4/113 (3.5%) | |
| Hypermetropia | 1/113 (0.9%) | |
| Lid sulcus deepened | 1/113 (0.9%) | |
| Myopia | 2/113 (1.8%) | |
| Ocular hyperaemia | 1/113 (0.9%) | |
| Photophobia | 1/113 (0.9%) | |
| Strabismus | 1/113 (0.9%) | |
| Vision blurred | 1/113 (0.9%) | |
| Gastrointestinal disorders | ||
| Abdominal discomfort | 3/113 (2.7%) | |
| Abdominal distension | 1/113 (0.9%) | |
| Abdominal pain | 10/113 (8.8%) | |
| Abdominal pain upper | 11/113 (9.7%) | |
| Abnormal faeces | 1/113 (0.9%) | |
| Anal fissure | 1/113 (0.9%) | |
| Aphthous stomatitis | 1/113 (0.9%) | |
| Constipation | 20/113 (17.7%) | |
| Dental caries | 3/113 (2.7%) | |
| Dental discomfort | 1/113 (0.9%) | |
| Diarrhoea | 55/113 (48.7%) | |
| Dysphagia | 2/113 (1.8%) | |
| Faecal incontinence | 1/113 (0.9%) | |
| Faeces discoloured | 2/113 (1.8%) | |
| Flatulence | 1/113 (0.9%) | |
| Frequent bowel movements | 1/113 (0.9%) | |
| Gastric ulcer | 1/113 (0.9%) | |
| Gastritis | 2/113 (1.8%) | |
| Gastrointestinal disorder | 4/113 (3.5%) | |
| Gastrooesophageal reflux disease | 4/113 (3.5%) | |
| Gingival bleeding | 1/113 (0.9%) | |
| Haematochezia | 2/113 (1.8%) | |
| Haemorrhoids | 1/113 (0.9%) | |
| Ileus | 1/113 (0.9%) | |
| Infrequent bowel movements | 1/113 (0.9%) | |
| Lip blister | 1/113 (0.9%) | |
| Lip ulceration | 1/113 (0.9%) | |
| Mouth ulceration | 1/113 (0.9%) | |
| Nausea | 12/113 (10.6%) | |
| Oral disorder | 1/113 (0.9%) | |
| Rectal fissure | 1/113 (0.9%) | |
| Regurgitation | 1/113 (0.9%) | |
| Retained deciduous tooth | 1/113 (0.9%) | |
| Retching | 1/113 (0.9%) | |
| Salivary hypersecretion | 2/113 (1.8%) | |
| Sensitivity of teeth | 1/113 (0.9%) | |
| Teething | 4/113 (3.5%) | |
| Tongue spasm | 1/113 (0.9%) | |
| Tooth deposit | 1/113 (0.9%) | |
| Tooth impacted | 1/113 (0.9%) | |
| Toothache | 2/113 (1.8%) | |
| Vomiting | 42/113 (37.2%) | |
| General disorders | ||
| Abasia | 1/113 (0.9%) | |
| Asthenia | 4/113 (3.5%) | |
| Catheter site erythema | 1/113 (0.9%) | |
| Catheter site extravasation | 4/113 (3.5%) | |
| Catheter site haemorrhage | 1/113 (0.9%) | |
| Catheter site inflammation | 1/113 (0.9%) | |
| Catheter site oedema | 1/113 (0.9%) | |
| Catheter site pain | 3/113 (2.7%) | |
| Catheter site rash | 1/113 (0.9%) | |
| Catheter site related reaction | 1/113 (0.9%) | |
| Catheter site swelling | 1/113 (0.9%) | |
| Chest discomfort | 3/113 (2.7%) | |
| Chest pain | 6/113 (5.3%) | |
| Chills | 2/113 (1.8%) | |
| Crepitations | 1/113 (0.9%) | |
| Device breakage | 1/113 (0.9%) | |
| Device dislocation | 4/113 (3.5%) | |
| Device issue | 1/113 (0.9%) | |
| Device malfunction | 9/113 (8%) | |
| Device occlusion | 13/113 (11.5%) | |
| Discomfort | 2/113 (1.8%) | |
| Disease progression | 1/113 (0.9%) | |
| Energy increased | 1/113 (0.9%) | |
| Extravasation | 2/113 (1.8%) | |
| Fatigue | 4/113 (3.5%) | |
| Feeling hot | 1/113 (0.9%) | |
| Gait disturbance | 1/113 (0.9%) | |
| Granuloma | 2/113 (1.8%) | |
| Gravitational oedema | 1/113 (0.9%) | |
| Influenza like illness | 1/113 (0.9%) | |
| Infusion site extravasation | 1/113 (0.9%) | |
| Infusion site swelling | 2/113 (1.8%) | |
| Injection site extravasation | 1/113 (0.9%) | |
| Injection site swelling | 1/113 (0.9%) | |
| Malaise | 2/113 (1.8%) | |
| Oedema | 3/113 (2.7%) | |
| Oedema peripheral | 2/113 (1.8%) | |
| Pain | 3/113 (2.7%) | |
| Peripheral swelling | 4/113 (3.5%) | |
| Pyrexia | 61/113 (54%) | |
| Secretion discharge | 6/113 (5.3%) | |
| Thirst | 1/113 (0.9%) | |
| Thrombosis in device | 1/113 (0.9%) | |
| Hepatobiliary disorders | ||
| Cholelithiasis | 1/113 (0.9%) | |
| Hepatic fibrosis | 1/113 (0.9%) | |
| Immune system disorders | ||
| Drug hypersensitivity | 2/113 (1.8%) | |
| Food allergy | 1/113 (0.9%) | |
| Hypersensitivity | 5/113 (4.4%) | |
| Multiple allergies | 1/113 (0.9%) | |
| Seasonal allergy | 2/113 (1.8%) | |
| Infections and infestations | ||
| Abscess limb | 1/113 (0.9%) | |
| Acarodermatitis | 1/113 (0.9%) | |
| Adenovirus infection | 1/113 (0.9%) | |
| Atypical pneumonia | 1/113 (0.9%) | |
| Bacterial tracheitis | 5/113 (4.4%) | |
| Beta haemolytic streptococcal infection | 1/113 (0.9%) | |
| Body tinea | 3/113 (2.7%) | |
| Bronchiolitis | 2/113 (1.8%) | |
| Bronchitis | 8/113 (7.1%) | |
| Candida infection | 1/113 (0.9%) | |
| Cellulitis | 1/113 (0.9%) | |
| Chronic sinusitis | 1/113 (0.9%) | |
| Clostridium difficile colitis | 2/113 (1.8%) | |
| Conjunctivitis | 7/113 (6.2%) | |
| Croup infectious | 2/113 (1.8%) | |
| Device related infection | 1/113 (0.9%) | |
| Ear infection | 12/113 (10.6%) | |
| Ear lobe infection | 1/113 (0.9%) | |
| Enterovirus infection | 1/113 (0.9%) | |
| Erythema infectiosum | 1/113 (0.9%) | |
| Escherichia urinary tract infection | 1/113 (0.9%) | |
| Eye infection | 2/113 (1.8%) | |
| Folliculitis | 1/113 (0.9%) | |
| Fungal infection | 2/113 (1.8%) | |
| Fungal skin infection | 1/113 (0.9%) | |
| Furuncle | 1/113 (0.9%) | |
| Gastroenteritis | 11/113 (9.7%) | |
| Gastroenteritis norovirus | 1/113 (0.9%) | |
| Gastroenteritis viral | 4/113 (3.5%) | |
| Gastrointestinal infection | 1/113 (0.9%) | |
| Gingival abscess | 1/113 (0.9%) | |
| Gingivitis | 1/113 (0.9%) | |
| Haemophilus infection | 1/113 (0.9%) | |
| Hand-foot-and-mouth disease | 1/113 (0.9%) | |
| Herpes zoster | 1/113 (0.9%) | |
| Hordeolum | 3/113 (2.7%) | |
| Impetigo | 1/113 (0.9%) | |
| Infection | 1/113 (0.9%) | |
| Influenza | 8/113 (7.1%) | |
| Labyrinthitis | 1/113 (0.9%) | |
| Lice infestation | 1/113 (0.9%) | |
| Lip infection | 1/113 (0.9%) | |
| Lobar pneumonia | 1/113 (0.9%) | |
| Nail infection | 1/113 (0.9%) | |
| Nasopharyngitis | 12/113 (10.6%) | |
| Oral candidiasis | 3/113 (2.7%) | |
| Oral herpes | 1/113 (0.9%) | |
| Otitis externa | 2/113 (1.8%) | |
| Otitis externa fungal | 1/113 (0.9%) | |
| Otitis media | 23/113 (20.4%) | |
| Otitis media acute | 6/113 (5.3%) | |
| Otitis media chronic | 3/113 (2.7%) | |
| Pharyngitis | 7/113 (6.2%) | |
| Pharyngitis streptococcal | 13/113 (11.5%) | |
| Pneumonia | 17/113 (15%) | |
| Pneumonia viral | 1/113 (0.9%) | |
| Pseudomonas infection | 4/113 (3.5%) | |
| Rash pustular | 1/113 (0.9%) | |
| Respiratory syncytial virus infection | 3/113 (2.7%) | |
| Respiratory tract infection | 5/113 (4.4%) | |
| Rhinitis | 6/113 (5.3%) | |
| Rhinovirus infection | 3/113 (2.7%) | |
| Rotavirus infection | 1/113 (0.9%) | |
| Sinusitis | 5/113 (4.4%) | |
| Skin infection | 1/113 (0.9%) | |
| Staphylococcal infection | 3/113 (2.7%) | |
| Stoma site infection | 2/113 (1.8%) | |
| Streptococcal infection | 2/113 (1.8%) | |
| Streptococcal urinary tract infection | 1/113 (0.9%) | |
| Subcutaneous abscess | 1/113 (0.9%) | |
| Tinea infection | 2/113 (1.8%) | |
| Tonsillitis | 2/113 (1.8%) | |
| Tooth abscess | 2/113 (1.8%) | |
| Tooth infection | 1/113 (0.9%) | |
| Tracheitis | 7/113 (6.2%) | |
| Tracheobronchitis | 1/113 (0.9%) | |
| Tracheostomy infection | 3/113 (2.7%) | |
| Upper respiratory tract infection | 49/113 (43.4%) | |
| Upper respiratory tract infection bacterial | 1/113 (0.9%) | |
| Urinary tract infection | 19/113 (16.8%) | |
| Viral infection | 15/113 (13.3%) | |
| Viral rash | 2/113 (1.8%) | |
| Viral upper respiratory tract infection | 5/113 (4.4%) | |
| Vulvovaginal mycotic infection | 1/113 (0.9%) | |
| Injury, poisoning and procedural complications | ||
| Agitation postoperative | 1/113 (0.9%) | |
| Animal bite | 1/113 (0.9%) | |
| Animal scratch | 1/113 (0.9%) | |
| Ankle fracture | 1/113 (0.9%) | |
| Arthropod bite | 7/113 (6.2%) | |
| Arthropod sting | 1/113 (0.9%) | |
| Concussion | 1/113 (0.9%) | |
| Contusion | 6/113 (5.3%) | |
| Exposure to communicable disease | 1/113 (0.9%) | |
| Eye contusion | 1/113 (0.9%) | |
| Eye injury | 1/113 (0.9%) | |
| Face injury | 1/113 (0.9%) | |
| Fall | 11/113 (9.7%) | |
| Feeding tube complication | 2/113 (1.8%) | |
| Femur fracture | 2/113 (1.8%) | |
| Foreign body | 1/113 (0.9%) | |
| Gastrointestinal anastomotic leak | 1/113 (0.9%) | |
| Gastrointestinal stoma complication | 1/113 (0.9%) | |
| Hand fracture | 1/113 (0.9%) | |
| Head injury | 3/113 (2.7%) | |
| Humerus fracture | 1/113 (0.9%) | |
| Joint dislocation | 2/113 (1.8%) | |
| Laceration | 6/113 (5.3%) | |
| Laryngeal injury | 1/113 (0.9%) | |
| Ligament sprain | 5/113 (4.4%) | |
| Limb injury | 2/113 (1.8%) | |
| Lower limb fracture | 1/113 (0.9%) | |
| Overdose | 1/113 (0.9%) | |
| Periorbital haemorrhage | 1/113 (0.9%) | |
| Post procedural haemorrhage | 2/113 (1.8%) | |
| Postoperative fever | 1/113 (0.9%) | |
| Postoperative respiratory distress | 1/113 (0.9%) | |
| Procedural nausea | 1/113 (0.9%) | |
| Procedural pain | 8/113 (7.1%) | |
| Procedural vomiting | 1/113 (0.9%) | |
| Scratch | 2/113 (1.8%) | |
| Skin abrasion | 9/113 (8%) | |
| Skin wound | 1/113 (0.9%) | |
| Soft tissue injury | 1/113 (0.9%) | |
| Splinter | 1/113 (0.9%) | |
| Stoma site erythema | 2/113 (1.8%) | |
| Stoma site haemorrhage | 2/113 (1.8%) | |
| Stoma site irritation | 3/113 (2.7%) | |
| Stoma site rash | 1/113 (0.9%) | |
| Stoma site reaction | 1/113 (0.9%) | |
| Sunburn | 1/113 (0.9%) | |
| Thermal burn | 2/113 (1.8%) | |
| Tibia fracture | 1/113 (0.9%) | |
| Tooth avulsion | 1/113 (0.9%) | |
| Tooth fracture | 1/113 (0.9%) | |
| Tooth injury | 1/113 (0.9%) | |
| Tracheostomy malfunction | 2/113 (1.8%) | |
| Vaccination complication | 2/113 (1.8%) | |
| Wound | 1/113 (0.9%) | |
| Wound dehiscence | 1/113 (0.9%) | |
| Investigations | ||
| Alanine aminotransferase abnormal | 1/113 (0.9%) | |
| Alanine aminotransferase increased | 3/113 (2.7%) | |
| Aspartate aminotransferase abnormal | 1/113 (0.9%) | |
| Aspartate aminotransferase increased | 4/113 (3.5%) | |
| Atrial pressure increased | 1/113 (0.9%) | |
| Blood alkaline phosphatase increased | 1/113 (0.9%) | |
| Blood creatine phosphokinase MB increased | 7/113 (6.2%) | |
| Blood creatine phosphokinase abnormal | 1/113 (0.9%) | |
| Blood creatine phosphokinase increased | 7/113 (6.2%) | |
| Blood culture positive | 1/113 (0.9%) | |
| Blood lactate dehydrogenase abnormal | 1/113 (0.9%) | |
| Blood lactate dehydrogenase increased | 2/113 (1.8%) | |
| Blood potassium decreased | 2/113 (1.8%) | |
| Blood pressure decreased | 2/113 (1.8%) | |
| Blood pressure increased | 7/113 (6.2%) | |
| Blood pressure systolic increased | 1/113 (0.9%) | |
| Blood uric acid decreased | 1/113 (0.9%) | |
| Blood uric acid increased | 1/113 (0.9%) | |
| Blood zinc decreased | 1/113 (0.9%) | |
| Body temperature increased | 5/113 (4.4%) | |
| Brain natriuretic peptide increased | 5/113 (4.4%) | |
| Breath sounds abnormal | 2/113 (1.8%) | |
| Creatine urine increased | 1/113 (0.9%) | |
| Creatinine urine increased | 1/113 (0.9%) | |
| Electrocardiogram PR shortened | 1/113 (0.9%) | |
| Electrocardiogram QT prolonged | 1/113 (0.9%) | |
| Electrocardiogram ST segment elevation | 1/113 (0.9%) | |
| Electrocardiogram abnormal | 2/113 (1.8%) | |
| Eosinophil count increased | 1/113 (0.9%) | |
| Gamma-glutamyltransferase increased | 1/113 (0.9%) | |
| Haematocrit decreased | 1/113 (0.9%) | |
| Haemoglobin decreased | 3/113 (2.7%) | |
| Heart rate increased | 5/113 (4.4%) | |
| Liver function test abnormal | 1/113 (0.9%) | |
| Neutrophil count abnormal | 1/113 (0.9%) | |
| Neutrophil count increased | 1/113 (0.9%) | |
| Neutrophil percentage increased | 1/113 (0.9%) | |
| Occult blood positive | 1/113 (0.9%) | |
| Oxygen saturation decreased | 4/113 (3.5%) | |
| Platelet count increased | 2/113 (1.8%) | |
| Protein urine | 1/113 (0.9%) | |
| Protein urine present | 1/113 (0.9%) | |
| Pulmonary function test decreased | 2/113 (1.8%) | |
| Pulse pressure abnormal | 1/113 (0.9%) | |
| Respiratory rate increased | 1/113 (0.9%) | |
| Serum ferritin decreased | 1/113 (0.9%) | |
| Specific gravity urine | 1/113 (0.9%) | |
| Sputum culture positive | 1/113 (0.9%) | |
| Staphylococcus test positive | 1/113 (0.9%) | |
| Tuberculin test positive | 1/113 (0.9%) | |
| Urine ketone body present | 1/113 (0.9%) | |
| Urine output decreased | 2/113 (1.8%) | |
| Weight decreased | 2/113 (1.8%) | |
| Weight increased | 3/113 (2.7%) | |
| White blood cell count abnormal | 1/113 (0.9%) | |
| White blood cell count increased | 1/113 (0.9%) | |
| Metabolism and nutrition disorders | ||
| Abnormal weight gain | 1/113 (0.9%) | |
| Decreased appetite | 4/113 (3.5%) | |
| Dehydration | 5/113 (4.4%) | |
| Electrolyte imbalance | 1/113 (0.9%) | |
| Failure to thrive | 1/113 (0.9%) | |
| Hypoalbuminaemia | 1/113 (0.9%) | |
| Hypochloraemia | 1/113 (0.9%) | |
| Hypoglycaemia | 3/113 (2.7%) | |
| Hypokalaemia | 2/113 (1.8%) | |
| Iron deficiency | 1/113 (0.9%) | |
| Vitamin D deficiency | 4/113 (3.5%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 5/113 (4.4%) | |
| Arthropathy | 1/113 (0.9%) | |
| Axillary mass | 1/113 (0.9%) | |
| Back pain | 2/113 (1.8%) | |
| Deformity thorax | 1/113 (0.9%) | |
| Foot deformity | 2/113 (1.8%) | |
| Fracture pain | 1/113 (0.9%) | |
| Hip deformity | 1/113 (0.9%) | |
| Joint contracture | 2/113 (1.8%) | |
| Joint stiffness | 1/113 (0.9%) | |
| Joint swelling | 3/113 (2.7%) | |
| Kyphosis | 2/113 (1.8%) | |
| Limb discomfort | 2/113 (1.8%) | |
| Muscle contracture | 1/113 (0.9%) | |
| Muscle spasms | 3/113 (2.7%) | |
| Muscle tightness | 2/113 (1.8%) | |
| Muscular weakness | 12/113 (10.6%) | |
| Musculoskeletal chest pain | 2/113 (1.8%) | |
| Musculoskeletal pain | 4/113 (3.5%) | |
| Musculoskeletal stiffness | 1/113 (0.9%) | |
| Myalgia | 1/113 (0.9%) | |
| Myopathy | 2/113 (1.8%) | |
| Neck pain | 3/113 (2.7%) | |
| Osteopenia | 4/113 (3.5%) | |
| Pain in extremity | 16/113 (14.2%) | |
| Pain in jaw | 1/113 (0.9%) | |
| Scoliosis | 6/113 (5.3%) | |
| Tendinous contracture | 2/113 (1.8%) | |
| Tendon discomfort | 3/113 (2.7%) | |
| Tendon disorder | 1/113 (0.9%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Cholesteatoma | 1/113 (0.9%) | |
| Nervous system disorders | ||
| Allodynia | 1/113 (0.9%) | |
| Areflexia | 2/113 (1.8%) | |
| Burning sensation | 1/113 (0.9%) | |
| Clumsiness | 1/113 (0.9%) | |
| Convulsion | 2/113 (1.8%) | |
| Dizziness | 3/113 (2.7%) | |
| Facial paresis | 1/113 (0.9%) | |
| Formication | 1/113 (0.9%) | |
| Gross motor delay | 2/113 (1.8%) | |
| Headache | 14/113 (12.4%) | |
| Hypoaesthesia | 1/113 (0.9%) | |
| Hyporeflexia | 2/113 (1.8%) | |
| Hypotonia | 2/113 (1.8%) | |
| Lethargy | 4/113 (3.5%) | |
| Motor developmental delay | 1/113 (0.9%) | |
| Motor dysfunction | 2/113 (1.8%) | |
| Muscle contractions involuntary | 1/113 (0.9%) | |
| Nystagmus | 1/113 (0.9%) | |
| Paraesthesia | 1/113 (0.9%) | |
| Paralysis flaccid | 1/113 (0.9%) | |
| Poor quality sleep | 1/113 (0.9%) | |
| Presyncope | 1/113 (0.9%) | |
| Psychomotor hyperactivity | 1/113 (0.9%) | |
| Somnolence | 1/113 (0.9%) | |
| Speech disorder | 1/113 (0.9%) | |
| Tremor | 2/113 (1.8%) | |
| Psychiatric disorders | ||
| Aggression | 1/113 (0.9%) | |
| Agitation | 4/113 (3.5%) | |
| Anxiety | 5/113 (4.4%) | |
| Attention deficit/hyperactivity disorder | 2/113 (1.8%) | |
| Bruxism | 1/113 (0.9%) | |
| Insomnia | 3/113 (2.7%) | |
| Irritability | 1/113 (0.9%) | |
| Mental disorder | 1/113 (0.9%) | |
| Mood swings | 1/113 (0.9%) | |
| Oppositional defiant disorder | 1/113 (0.9%) | |
| Sleep disorder | 2/113 (1.8%) | |
| Renal and urinary disorders | ||
| Dysuria | 2/113 (1.8%) | |
| Haematuria | 1/113 (0.9%) | |
| Incontinence | 1/113 (0.9%) | |
| Nephrolithiasis | 1/113 (0.9%) | |
| Pollakiuria | 2/113 (1.8%) | |
| Proteinuria | 1/113 (0.9%) | |
| Urinary hesitation | 1/113 (0.9%) | |
| Urinary incontinence | 4/113 (3.5%) | |
| Urinary retention | 1/113 (0.9%) | |
| Reproductive system and breast disorders | ||
| Genital discomfort | 2/113 (1.8%) | |
| Vaginal prolapse | 1/113 (0.9%) | |
| Vulvovaginal disorder | 1/113 (0.9%) | |
| Vulvovaginal erythema | 2/113 (1.8%) | |
| Vulvovaginal pruritus | 1/113 (0.9%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Adenoidal hypertrophy | 1/113 (0.9%) | |
| Aspiration | 2/113 (1.8%) | |
| Atelectasis | 5/113 (4.4%) | |
| Bronchial hyperreactivity | 3/113 (2.7%) | |
| Bronchial secretion retention | 3/113 (2.7%) | |
| Bronchial wall thickening | 1/113 (0.9%) | |
| Bronchomalacia | 1/113 (0.9%) | |
| Bronchospasm | 1/113 (0.9%) | |
| Choking | 3/113 (2.7%) | |
| Cough | 36/113 (31.9%) | |
| Dysphonia | 1/113 (0.9%) | |
| Dyspnoea | 6/113 (5.3%) | |
| Epistaxis | 5/113 (4.4%) | |
| Haemoptysis | 3/113 (2.7%) | |
| Hypercapnia | 1/113 (0.9%) | |
| Hypoventilation | 2/113 (1.8%) | |
| Hypoxia | 1/113 (0.9%) | |
| Increased bronchial secretion | 5/113 (4.4%) | |
| Increased upper airway secretion | 7/113 (6.2%) | |
| Increased viscosity of bronchial secretion | 3/113 (2.7%) | |
| Nasal congestion | 16/113 (14.2%) | |
| Nasal discharge discolouration | 1/113 (0.9%) | |
| Nasal dryness | 1/113 (0.9%) | |
| Oropharyngeal pain | 13/113 (11.5%) | |
| Pleural effusion | 1/113 (0.9%) | |
| Pneumonia aspiration | 3/113 (2.7%) | |
| Productive cough | 2/113 (1.8%) | |
| Pulmonary artery dilatation | 1/113 (0.9%) | |
| Pulmonary congestion | 1/113 (0.9%) | |
| Pulmonary hypertension | 1/113 (0.9%) | |
| Respiratory disorder | 1/113 (0.9%) | |
| Respiratory distress | 8/113 (7.1%) | |
| Respiratory failure | 1/113 (0.9%) | |
| Respiratory muscle weakness | 3/113 (2.7%) | |
| Respiratory tract congestion | 7/113 (6.2%) | |
| Respiratory tract haemorrhage | 2/113 (1.8%) | |
| Rhinitis allergic | 2/113 (1.8%) | |
| Rhinorrhoea | 24/113 (21.2%) | |
| Rhonchi | 2/113 (1.8%) | |
| Sinus congestion | 2/113 (1.8%) | |
| Sleep apnoea syndrome | 4/113 (3.5%) | |
| Sneezing | 2/113 (1.8%) | |
| Snoring | 1/113 (0.9%) | |
| Sputum discoloured | 1/113 (0.9%) | |
| Sputum increased | 1/113 (0.9%) | |
| Tachypnoea | 1/113 (0.9%) | |
| Throat irritation | 3/113 (2.7%) | |
| Throat tightness | 1/113 (0.9%) | |
| Tonsillar hypertrophy | 2/113 (1.8%) | |
| Tracheal ulcer | 1/113 (0.9%) | |
| Upper respiratory tract congestion | 8/113 (7.1%) | |
| Upper-airway cough syndrome | 1/113 (0.9%) | |
| Use of accessory respiratory muscles | 1/113 (0.9%) | |
| Wheezing | 5/113 (4.4%) | |
| Skin and subcutaneous tissue disorders | ||
| Acne | 3/113 (2.7%) | |
| Alopecia | 2/113 (1.8%) | |
| Blister | 1/113 (0.9%) | |
| Cold sweat | 1/113 (0.9%) | |
| Decubitus ulcer | 3/113 (2.7%) | |
| Dermatitis | 3/113 (2.7%) | |
| Dermatitis allergic | 1/113 (0.9%) | |
| Dermatitis contact | 2/113 (1.8%) | |
| Dermatitis diaper | 4/113 (3.5%) | |
| Dry skin | 2/113 (1.8%) | |
| Ecchymosis | 1/113 (0.9%) | |
| Eczema | 2/113 (1.8%) | |
| Erythema | 5/113 (4.4%) | |
| Excessive granulation tissue | 4/113 (3.5%) | |
| Granuloma skin | 1/113 (0.9%) | |
| Hyperhidrosis | 1/113 (0.9%) | |
| Hyperkeratosis | 1/113 (0.9%) | |
| Ingrowing nail | 1/113 (0.9%) | |
| Ingrown hair | 1/113 (0.9%) | |
| Macule | 2/113 (1.8%) | |
| Mechanical urticaria | 1/113 (0.9%) | |
| Papule | 1/113 (0.9%) | |
| Petechiae | 1/113 (0.9%) | |
| Photosensitivity reaction | 1/113 (0.9%) | |
| Pruritus | 5/113 (4.4%) | |
| Pruritus generalised | 1/113 (0.9%) | |
| Rash | 31/113 (27.4%) | |
| Rash erythematous | 2/113 (1.8%) | |
| Rash macular | 1/113 (0.9%) | |
| Rash pruritic | 1/113 (0.9%) | |
| Red man syndrome | 1/113 (0.9%) | |
| Seborrhoeic dermatitis | 1/113 (0.9%) | |
| Skin disorder | 2/113 (1.8%) | |
| Skin exfoliation | 2/113 (1.8%) | |
| Skin hyperpigmentation | 1/113 (0.9%) | |
| Skin irritation | 4/113 (3.5%) | |
| Skin lesion | 2/113 (1.8%) | |
| Skin ulcer | 2/113 (1.8%) | |
| Swelling face | 1/113 (0.9%) | |
| Urticaria | 9/113 (8%) | |
| Surgical and medical procedures | ||
| Central venous catheterisation | 1/113 (0.9%) | |
| Ear tube removal | 1/113 (0.9%) | |
| Gastrostomy tube removal | 1/113 (0.9%) | |
| Vascular disorders | ||
| Aortic dilatation | 1/113 (0.9%) | |
| Flushing | 7/113 (6.2%) | |
| Haematoma | 2/113 (1.8%) | |
| Hypertension | 5/113 (4.4%) | |
| Hypotension | 2/113 (1.8%) | |
| Pallor | 1/113 (0.9%) | |
| Peripheral coldness | 1/113 (0.9%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
| Name/Title | Trial Transparency Team |
|---|---|
| Organization | Sanofi |
| Phone | |
| Contact-US@sanofi.com |
Responsible Party:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01526785
Other Study ID Numbers:
- AGLU09411
- EFC12720
First Posted:
Feb 6, 2012
Last Update Posted:
Dec 8, 2015
Last Verified:
Nov 1, 2015