Trial Outcomes & Findings for Best African American Response to Asthma Drugs (NCT NCT01967173)

NCT ID: NCT01967173

Last Updated: 2018-11-15

Results Overview

This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

574 participants

Primary outcome timeframe

The last 12 weeks of each 14-week treatment period

Results posted on

2018-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Crossover Sequence 1 Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 2 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 3 Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 4 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 5 Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 6 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 7 Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 8 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination
Overall Study STARTED	69	69	71	71	73	72	75	74
Overall Study Completed 1st Period	58	60	67	65	64	62	67	69
Overall Study Completed 2nd Period	52	58	63	62	63	57	63	61
Overall Study Completed 3rd Period	48	54	60	61	59	56	59	56
Overall Study Completed 4th Period	45	52	55	57	56	49	57	50
Overall Study COMPLETED	45	52	55	57	56	49	57	50
Overall Study NOT COMPLETED	24	17	16	14	17	23	18	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Crossover Sequence 1 Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 2 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 3 Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 4 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 5 Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 6 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 7 Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 8 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination
Overall Study Lost to Follow-up	5	3	2	4	8	12	6	8
Overall Study Physician Decision	2	0	2	1	1	1	1	0
Overall Study Lack of Efficacy	2	0	2	2	0	1	0	2
Overall Study Pregnancy	0	0	0	0	0	0	1	1
Overall Study Adverse Event	0	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	15	14	10	7	8	9	10	12

Baseline Characteristics

Asthma Control Test is not validated for use in children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crossover Sequence 1 n=69 Participants Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 2 n=69 Participants Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 3 n=71 Participants Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 4 n=71 Participants Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 100 mcg: Flovent is an ICS Flovent Diskus® 250 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 5 n=73 Participants Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 6 n=72 Participants Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 7 n=75 Participants Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Crossover Sequence 8 n=74 Participants Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Flovent Diskus® 250 mcg: Flovent is an ICS Flovent Diskus® 500 mcg: Flovent is an ICS Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination	Total n=574 Participants Total of all reporting groups
Age, Continuous	8.7 years STANDARD_DEVIATION 2.0 • n=69 Participants	8.5 years STANDARD_DEVIATION 1.7 • n=69 Participants	8.4 years STANDARD_DEVIATION 1.9 • n=71 Participants	8.4 years STANDARD_DEVIATION 1.8 • n=71 Participants	38.5 years STANDARD_DEVIATION 16.5 • n=73 Participants	38.5 years STANDARD_DEVIATION 15.9 • n=72 Participants	39.3 years STANDARD_DEVIATION 16.0 • n=75 Participants	35.6 years STANDARD_DEVIATION 16.0 • n=74 Participants	23.2 years STANDARD_DEVIATION 18.5 • n=574 Participants
Sex: Female, Male Female	29 Participants n=69 Participants	27 Participants n=69 Participants	26 Participants n=71 Participants	28 Participants n=71 Participants	52 Participants n=73 Participants	48 Participants n=72 Participants	47 Participants n=75 Participants	52 Participants n=74 Participants	309 Participants n=574 Participants
Sex: Female, Male Male	40 Participants n=69 Participants	42 Participants n=69 Participants	45 Participants n=71 Participants	43 Participants n=71 Participants	21 Participants n=73 Participants	24 Participants n=72 Participants	28 Participants n=75 Participants	22 Participants n=74 Participants	265 Participants n=574 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=69 Participants	4 Participants n=69 Participants	7 Participants n=71 Participants	6 Participants n=71 Participants	2 Participants n=73 Participants	2 Participants n=72 Participants	2 Participants n=75 Participants	3 Participants n=74 Participants	33 Participants n=574 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=69 Participants	65 Participants n=69 Participants	64 Participants n=71 Participants	65 Participants n=71 Participants	71 Participants n=73 Participants	70 Participants n=72 Participants	73 Participants n=75 Participants	71 Participants n=74 Participants	541 Participants n=574 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=69 Participants	0 Participants n=69 Participants	0 Participants n=71 Participants	0 Participants n=71 Participants	0 Participants n=73 Participants	0 Participants n=72 Participants	0 Participants n=75 Participants	0 Participants n=74 Participants	0 Participants n=574 Participants
Race/Ethnicity, Customized Black	63 Participants n=69 Participants	65 Participants n=69 Participants	68 Participants n=71 Participants	66 Participants n=71 Participants	69 Participants n=73 Participants	71 Participants n=72 Participants	74 Participants n=75 Participants	73 Participants n=74 Participants	549 Participants n=574 Participants
Race/Ethnicity, Customized Other	6 Participants n=69 Participants	4 Participants n=69 Participants	3 Participants n=71 Participants	5 Participants n=71 Participants	4 Participants n=73 Participants	1 Participants n=72 Participants	1 Participants n=75 Participants	1 Participants n=74 Participants	25 Participants n=574 Participants
Region of Enrollment United States	69 participants n=69 Participants	69 participants n=69 Participants	71 participants n=71 Participants	71 participants n=71 Participants	73 participants n=73 Participants	72 participants n=72 Participants	75 participants n=75 Participants	74 participants n=74 Participants	574 participants n=574 Participants
Forced expiratory volume at one second (FEV1) Percent of Predicted	98.1 percent STANDARD_DEVIATION 15.4 • n=69 Participants	92.6 percent STANDARD_DEVIATION 17.9 • n=69 Participants	95 percent STANDARD_DEVIATION 13.6 • n=71 Participants	96.2 percent STANDARD_DEVIATION 19.1 • n=71 Participants	83.8 percent STANDARD_DEVIATION 19.1 • n=73 Participants	82.9 percent STANDARD_DEVIATION 15.5 • n=72 Participants	83.7 percent STANDARD_DEVIATION 17.3 • n=75 Participants	83.4 percent STANDARD_DEVIATION 18 • n=74 Participants	89.3 percent STANDARD_DEVIATION 18.1 • n=574 Participants
Asthma Control Test	—	—	—	—	18.9 units on a scale STANDARD_DEVIATION 3.8 • n=73 Participants • Asthma Control Test is not validated for use in children	18.6 units on a scale STANDARD_DEVIATION 3.9 • n=72 Participants • Asthma Control Test is not validated for use in children	19.2 units on a scale STANDARD_DEVIATION 3.7 • n=75 Participants • Asthma Control Test is not validated for use in children	18.8 units on a scale STANDARD_DEVIATION 3.8 • n=74 Participants • Asthma Control Test is not validated for use in children	18.9 units on a scale STANDARD_DEVIATION 3.8 • n=294 Participants • Asthma Control Test is not validated for use in children
Childhood Asthma Control Test	21.5 units on a scale STANDARD_DEVIATION 3.7 • n=69 Participants • Childhood Asthma Control Test is not validated for use in adults	21.2 units on a scale STANDARD_DEVIATION 3.6 • n=69 Participants • Childhood Asthma Control Test is not validated for use in adults	20.7 units on a scale STANDARD_DEVIATION 4.1 • n=71 Participants • Childhood Asthma Control Test is not validated for use in adults	22.1 units on a scale STANDARD_DEVIATION 3.6 • n=71 Participants • Childhood Asthma Control Test is not validated for use in adults	—	—	—	—	21.4 units on a scale STANDARD_DEVIATION 3.8 • n=280 Participants • Childhood Asthma Control Test is not validated for use in adults

PRIMARY outcome

Timeframe: The last 12 weeks of each 14-week treatment period

Population: Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults

Outcome measures

Outcome measures
Measure	Adolescents and Adults n=294 Participants All study participant age 12 years or greater	Children n=280 Participants All study participants under age 12 years
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 superior to Flovent 250	.49 probability	.46 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 inferior to Flovent 250	.28 probability	.46 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 superior to Flovent 500	.53 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 inferior to Flovent 500	.27 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 superior to Advair 250/50	.42 probability	.47 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 inferior to Advair 250/50	.36 probability	.49 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 superior to Flovent 100	—	.53 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 100/50 inferior to Flovent 100	—	.41 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 250/50 superior to Flovent 250	.46 probability	.43 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 250/50 inferior to Flovent 250	.33 probability	.47 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 250/50 superior to Flovent 500	.49 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Advair 250/50 inferior to Flovent 500	.31 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Flovent 500 superior to Flovent 250	.35 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Flovent 500 inferior to Flovent 250	.40 probability	—
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Flovent 250 superior to Flovent 100	—	.51 probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. Flovent 250 inferior to Flovent 100	—	.37 probability

Adverse Events

Flovent 250 in Pediatric Group

Serious events: 8 serious events

Other events: 64 other events

Deaths: 0 deaths

Advair 250/50 in Pediatric Group

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Flovent 100 in Pediatric Group

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Advair 100/50 in Pediatric Group

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

Flovent 500 in Adolescent/Adult Group

Serious events: 10 serious events

Other events: 53 other events

Deaths: 0 deaths

Advair 250/50 in Adolescent/Adult Group

Serious events: 7 serious events

Other events: 47 other events

Deaths: 0 deaths

Flovent 250 in Adolescent/Adult Group

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Advair 100/50 in Adolescent/Adult Group

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flovent 250 in Pediatric Group n=280 participants at risk Flovent 250 in participants under 12 years	Advair 250/50 in Pediatric Group n=280 participants at risk Advair 250/50 in participants under 12 years	Flovent 100 in Pediatric Group n=280 participants at risk Flovent 100 in participants under 12 years	Advair 100/50 in Pediatric Group n=280 participants at risk Advair 100/50 in participants under 12 years	Flovent 500 in Adolescent/Adult Group n=294 participants at risk Flovent 500 in participants 12 years and older	Advair 250/50 in Adolescent/Adult Group n=294 participants at risk Advair 250/50 in participants 12 years and older	Flovent 250 in Adolescent/Adult Group n=294 participants at risk Flovent 250 in participants 12 years and older	Advair 100/50 in Adolescent/Adult Group n=294 participants at risk Advair 100/50 in participants 12 years and older
Psychiatric disorders Drug Withdrawal	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Psychiatric disorders Intermittent Explosive Disorder	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Blood and lymphatic system disorders Anemia	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Cardiac disorders Acute Pericarditis	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Gastrointestinal disorders Acute Gastritis	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Gastrointestinal disorders Acute Peptic Ulcer	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Renal and urinary disorders Acute Kidney Failure	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Musculoskeletal and connective tissue disorders Lumbar Spinal Cord Compression	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Nervous system disorders Acute Post-Op Pain	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Nervous system disorders Migraine	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	2.1% 6/280 • Number of events 6 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.71% 2/280 • Number of events 2 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.4% 4/294 • Number of events 4 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.68% 2/294 • Number of events 2 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.0% 3/294 • Number of events 3 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.68% 2/294 • Number of events 2 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Respiratory, thoracic and mediastinal disorders Flu	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Injury, poisoning and procedural complications Adverse Food Reaction	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Injury, poisoning and procedural complications Anaphylactic Shock	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Injury, poisoning and procedural complications Closed Fracture	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Psychiatric disorders Major Depression	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Brain	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Thyroid	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Psychiatric disorders Altered Mental Status	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Gastrointestinal disorders Chest Pain Not Elsewhere Classified	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
General disorders Convulsions Not Elsewhere Classified	0.36% 1/280 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
General disorders Syncope and Collapse	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/280 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.34% 1/294 • Number of events 1 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.

Other adverse events

Other adverse events
Measure	Flovent 250 in Pediatric Group n=280 participants at risk Flovent 250 in participants under 12 years	Advair 250/50 in Pediatric Group n=280 participants at risk Advair 250/50 in participants under 12 years	Flovent 100 in Pediatric Group n=280 participants at risk Flovent 100 in participants under 12 years	Advair 100/50 in Pediatric Group n=280 participants at risk Advair 100/50 in participants under 12 years	Flovent 500 in Adolescent/Adult Group n=294 participants at risk Flovent 500 in participants 12 years and older	Advair 250/50 in Adolescent/Adult Group n=294 participants at risk Advair 250/50 in participants 12 years and older	Flovent 250 in Adolescent/Adult Group n=294 participants at risk Flovent 250 in participants 12 years and older	Advair 100/50 in Adolescent/Adult Group n=294 participants at risk Advair 100/50 in participants 12 years and older
Respiratory, thoracic and mediastinal disorders Acute Nasopharyngitis	7.1% 20/280 • Number of events 35 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.4% 18/280 • Number of events 36 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.8% 19/280 • Number of events 33 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	7.1% 20/280 • Number of events 39 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	8.2% 24/294 • Number of events 33 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	9.2% 27/294 • Number of events 46 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.8% 20/294 • Number of events 40 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	7.5% 22/294 • Number of events 42 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Respiratory, thoracic and mediastinal disorders Acute Upper Respiratory Tract Infection	5.7% 16/280 • Number of events 25 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.6% 10/280 • Number of events 14 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.9% 11/280 • Number of events 16 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.9% 11/280 • Number of events 20 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.7% 11/294 • Number of events 19 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.7% 11/294 • Number of events 15 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	5.4% 16/294 • Number of events 24 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	4.4% 13/294 • Number of events 20 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	8.2% 23/280 • Number of events 41 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	7.1% 20/280 • Number of events 47 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	14.3% 40/280 • Number of events 54 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.4% 18/280 • Number of events 31 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.1% 18/294 • Number of events 20 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	5.8% 17/294 • Number of events 20 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	5.8% 17/294 • Number of events 22 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	6.1% 18/294 • Number of events 23 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
General disorders Cough	3.9% 11/280 • Number of events 20 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	3.6% 10/280 • Number of events 23 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	4.6% 13/280 • Number of events 24 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	5.4% 15/280 • Number of events 21 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.68% 2/294 • Number of events 2 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.0% 3/294 • Number of events 5 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	2.0% 6/294 • Number of events 7 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.0% 3/294 • Number of events 3 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.
General disorders Fever	3.6% 10/280 • Number of events 11 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	2.1% 6/280 • Number of events 8 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	5.7% 16/280 • Number of events 19 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	2.9% 8/280 • Number of events 10 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.4% 4/294 • Number of events 4 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.0% 3/294 • Number of events 3 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	0.00% 0/294 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.	1.4% 4/294 • Number of events 5 • Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.

Additional Information

David Mauger

Penn State University

Phone: 717-531-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place