Trial Outcomes & Findings for Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to <4 Years (NCT NCT03273946)

Last Updated: 2019-10-02

Results Overview

An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.

Recruitment status

COMPLETED

Target enrollment

158 participants

Primary outcome timeframe

Up to Week 12

Results posted on

2019-10-02

Participant Flow

This was a single arm non-interventional, post-marketing safety monitoring study to evaluate safety of Chinese participants aged 1 to \<4 years when using Flixotide 50 micrograms (μg) via a pediatric spacer device with a face mask in clinical practice. No medical intervention was received by participants during conduct of this study.

Total 158 participants were enrolled into this study. The study was conducted at 4 centers in China.

Participant milestones

Participant milestones
Measure	All Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Overall Study STARTED	158
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Overall Study Withdrawal by Subject	5
Overall Study Unwillingness of the guardian	1
Overall Study Participant refused to use the drug	2
Overall Study Participant relative refused to use drug	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=158 Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Age, Continuous	33.40 Months STANDARD_DEVIATION 10.98 • n=158 Participants
Sex: Female, Male Female	58 Participants n=158 Participants
Sex: Female, Male Male	100 Participants n=158 Participants
Region of Enrollment China · China	158 Participants n=158 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Population. It was defined as all the participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.

Outcome measures

Outcome measures
Measure	All Participants n=158 Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR) Any AE	110 Participants
Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR) Any ADR	0 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Population

Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.

Outcome measures

Outcome measures
Measure	All Participants n=158 Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE Any non-SAE	104 Participants
Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE Any SAE	6 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Population

An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.

Outcome measures

Outcome measures
Measure	All Participants n=158 Participants The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Number of Participants With Any New, Unexpected AE or Safety Signal Any unexpected AE	0 Participants
Number of Participants With Any New, Unexpected AE or Safety Signal Any safety signal	0 Participants

Adverse Events

All Participants

Serious events: 6 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=158 participants at risk The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Infections and infestations Pneumonia	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Respiratory, thoracic and mediastinal disorders Asthma	1.3% 2/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.

Other adverse events

Other adverse events
Measure	All Participants n=158 participants at risk The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.
Infections and infestations Upper respiratory tract infection	29.7% 47/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Bronchitis	21.5% 34/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Rhinitis	5.7% 9/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Pharyngitis	5.1% 8/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Herpangina	5.1% 8/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Pneumonia	1.9% 3/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Rhinopharyngitis	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Sinusitis	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Tonsillitis	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Viral infection	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Mycoplasma infection	1.9% 3/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Otitis media	1.3% 2/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Herpes pharyngitis	1.3% 2/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Molluscum contagious	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Laryngitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Conjunctivitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Folliculitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Parotitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Upper respiratory tract infection bacterial	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Hand-foot-and-mouth disease	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Varicella	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Gastroenteritis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Infections and infestations Bacterial infection	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
General disorders Pyrexia	20.3% 32/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
General disorders Influenza like illness	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
General disorders Systemic inflammatory response syndrome	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
General disorders Sensation of foreign body	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Diarrhoea	3.2% 5/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Vomiting	3.2% 5/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Constipation	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Enteritis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Nausea	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Pain abdominal	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Stomach inflammation	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Gastrointestinal disorders Indigestion	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Skin and subcutaneous tissue disorders Dermatitis	3.2% 5/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Skin and subcutaneous tissue disorders Eczema	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Skin and subcutaneous tissue disorders Miliaria	1.3% 2/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Skin and subcutaneous tissue disorders Skin exfoliation	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Skin and subcutaneous tissue disorders Urticarial rash	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Respiratory, thoracic and mediastinal disorders Coughing	2.5% 4/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Respiratory, thoracic and mediastinal disorders Asthma	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Respiratory, thoracic and mediastinal disorders Wheezing	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Reproductive system and breast disorders Balanoposthitis	1.3% 2/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Metabolism and nutrition disorders Decreased appetite	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Hepatobiliary disorders Abnormal hepatic function	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Investigations Red blood cells urine	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Nervous system disorders Febrile convulsion	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Musculoskeletal and connective tissue disorders Synovitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Congenital, familial and genetic disorders Ankyloglossia congenital	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.
Blood and lymphatic system disorders Lymphadenitis	0.63% 1/158 • In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study. Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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