Trial Outcomes & Findings for 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old (NCT NCT01462344)
NCT ID: NCT01462344
Last Updated: 2018-08-06
Results Overview
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6250 participants
Primary outcome timeframe
From Day 1 up to 6 months
Results posted on
2018-08-06
Participant Flow
A total of 6250 participants were enrolled and randomized to study treatments; total 6208 participants took at least one dose of study drug.
Participants aged between 4 to 11 years having asthma, defined by the regional asthma guidelines for at least 6 months, having history of at least one occurrence of treatment with systemic corticosteroid and with no change in asthma therapy for the last 4 weeks from first visit were enrolled for the study.
Participant milestones
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
Fluticasone Propionate (FP)
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
3107
|
3101
|
|
Overall Study
COMPLETED
|
2724
|
2751
|
|
Overall Study
NOT COMPLETED
|
383
|
350
|
Reasons for withdrawal
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
Fluticasone Propionate (FP)
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
245
|
226
|
|
Overall Study
Adverse Event
|
24
|
23
|
|
Overall Study
Asthma Exacerbation
|
34
|
35
|
|
Overall Study
Lack of Efficacy
|
5
|
6
|
|
Overall Study
Protocol Violation
|
68
|
53
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
Baseline Characteristics
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
Baseline characteristics by cohort
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
Total
n=6208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 Years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
7.6 Years
STANDARD_DEVIATION 2.20 • n=7 Participants
|
7.6 Years
STANDARD_DEVIATION 2.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1187 Participants
n=5 Participants
|
1227 Participants
n=7 Participants
|
2414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1920 Participants
n=5 Participants
|
1874 Participants
n=7 Participants
|
3794 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American / African Heritage
|
539 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
1050 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
144 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central / South Asian Heritage
|
30 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
96 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
122 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White / Caucasian / European Heritage
|
1985 Participants
n=5 Participants
|
2017 Participants
n=7 Participants
|
4002 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
167 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: ITT Population
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
Outcome measures
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
|
27 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: mITT Population
Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.
Outcome measures
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
|
265 Participants
|
309 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: ITT Population
Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.
Outcome measures
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: ITT Population
Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.
Outcome measures
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: ITT Population
Hospitalization is defined as a \>=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.
Outcome measures
| Measure |
FSC DPI
n=3107 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
|
27 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: mITT Population
An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.
Outcome measures
| Measure |
FSC DPI
n=265 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=309 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
|
33 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: mITT Population
Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
Outcome measures
| Measure |
FSC DPI
n=3049 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3036 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Percentage of Rescue-free Days Over the 6-month Study Treatment Period
|
83.0 Percentage of rescue-free days
Standard Error 0.50
|
81.9 Percentage of rescue-free days
Standard Error 0.52
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 monthsPopulation: mITT Population
An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was \<=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
Outcome measures
| Measure |
FSC DPI
n=2936 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=2935 Participants
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Percentage of Asthma Control Days Over the 6-month Study Treatment Period
|
74.8 Percentage of asthma control days
Standard Error 0.57
|
73.4 Percentage of asthma control days
Standard Error 0.58
|
Adverse Events
FSC DPI
Serious events: 56 serious events
Other events: 31 other events
Deaths: 0 deaths
FP DPI
Serious events: 54 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FSC DPI
n=3107 participants at risk
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 participants at risk
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.35%
11/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.26%
8/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Bronchitis
|
0.10%
3/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Infectious mononucleosis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Influenza
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Viral myositis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Viral tonsillitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.74%
23/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.42%
13/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Renal and urinary disorders
Haematuria
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Renal and urinary disorders
Nephritis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
General disorders
Effusion
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
Other adverse events
| Measure |
FSC DPI
n=3107 participants at risk
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
|
FP DPI
n=3101 participants at risk
Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
15/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.74%
23/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.06%
2/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
2/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Infections and infestations
Rhinitis
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Nervous system disorders
Headache
|
0.06%
2/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.06%
2/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Nervous system disorders
Tremor
|
0.06%
2/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Psychiatric disorders
Insomnia
|
0.06%
2/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Psychiatric disorders
Irritability
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.00%
0/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
General disorders
Chest discomfort
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.00%
0/3107 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
0.03%
1/3101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 6 months).
Due to the extensive safety database of FSC, FP, and albuterol/salbutamol, and the outcomes of interest in this study, the only non-serious AEs that were collected in this study are those that lead to study drug discontinuation.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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.
- Publication restrictions are in place
Restriction type: OTHER