Trial Outcomes & Findings for Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED) (NCT NCT00383721)
NCT ID: NCT00383721
Last Updated: 2024-05-23
Results Overview
FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1196 participants
Primary outcome timeframe
Baseline to Endpoint (13 weeks)
Results posted on
2024-05-23
Participant Flow
At Week 26, all participants randomized to placebo were to be discontinued, while 75% of participants randomized to an active treatment were randomly selected to participate in the 26-week Treatment Safety Extension. Several placebo-treated participants continued in error into the Treatment Safety Extension.
Participant milestones
| Measure |
MF/F MDI 400/10 mcg BID
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
26-Week Double-Blind Treatment Period
STARTED
|
225
|
239
|
253
|
243
|
236
|
|
26-Week Double-Blind Treatment Period
COMPLETED
|
190
|
202
|
202
|
193
|
169
|
|
26-Week Double-Blind Treatment Period
NOT COMPLETED
|
35
|
37
|
51
|
50
|
67
|
|
26-Week Treatment Safety Extension
STARTED
|
145
|
153
|
149
|
148
|
8
|
|
26-Week Treatment Safety Extension
COMPLETED
|
126
|
136
|
126
|
131
|
8
|
|
26-Week Treatment Safety Extension
NOT COMPLETED
|
19
|
17
|
23
|
17
|
0
|
Reasons for withdrawal
| Measure |
MF/F MDI 400/10 mcg BID
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
26-Week Double-Blind Treatment Period
Adverse Event
|
11
|
5
|
7
|
14
|
13
|
|
26-Week Double-Blind Treatment Period
Lack of Efficacy
|
1
|
3
|
3
|
4
|
8
|
|
26-Week Double-Blind Treatment Period
Lost to Follow-up
|
0
|
0
|
2
|
1
|
4
|
|
26-Week Double-Blind Treatment Period
Participant withdrawal unrelated
|
4
|
12
|
15
|
10
|
11
|
|
26-Week Double-Blind Treatment Period
Participant withdrawal related
|
5
|
3
|
6
|
8
|
9
|
|
26-Week Double-Blind Treatment Period
Non-compliance with protocol
|
7
|
5
|
4
|
6
|
6
|
|
26-Week Double-Blind Treatment Period
Did not meet protocol eligibility
|
5
|
6
|
11
|
4
|
13
|
|
26-Week Double-Blind Treatment Period
Administrative
|
1
|
3
|
3
|
3
|
3
|
|
26-Week Double-Blind Treatment Period
Ongoing
|
1
|
0
|
0
|
0
|
0
|
|
26-Week Treatment Safety Extension
Adverse Event
|
6
|
7
|
10
|
1
|
0
|
|
26-Week Treatment Safety Extension
Lack of Efficacy
|
0
|
2
|
4
|
1
|
0
|
|
26-Week Treatment Safety Extension
Lost to Follow-up
|
2
|
0
|
1
|
1
|
0
|
|
26-Week Treatment Safety Extension
Participant withdrawal unrelated
|
6
|
4
|
2
|
7
|
0
|
|
26-Week Treatment Safety Extension
Participant withdrawal related
|
1
|
1
|
1
|
1
|
0
|
|
26-Week Treatment Safety Extension
Non-compliance with protocol
|
2
|
1
|
1
|
4
|
0
|
|
26-Week Treatment Safety Extension
Did not meet protocol eligibility
|
1
|
0
|
1
|
1
|
0
|
|
26-Week Treatment Safety Extension
Administrative
|
1
|
2
|
3
|
1
|
0
|
Baseline Characteristics
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MF/F MDI 400/10 mcg BID
n=225 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=239 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=253 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=243 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=236 Participants
Placebo MDI BID for 26 weeks.
|
Total
n=1196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
58.8 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
59.7 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
296 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
178 Participants
n=21 Participants
|
900 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Endpoint (13 weeks)Population: Intent-to-treat (ITT) population
FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=216 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=230 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=246 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=236 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=225 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
Baseline
|
1.189 Liters
Standard Deviation 0.408
|
1.195 Liters
Standard Deviation 0.408
|
1.260 Liters
Standard Deviation 0.408
|
1.176 Liters
Standard Deviation 0.408
|
1.205 Liters
Standard Deviation 0.408
|
|
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
Endpoint (Change from Baseline)
|
0.179 Liters
Standard Deviation 0.274
|
0.139 Liters
Standard Deviation 0.274
|
0.053 Liters
Standard Deviation 0.274
|
0.092 Liters
Standard Deviation 0.274
|
0.018 Liters
Standard Deviation 0.274
|
PRIMARY outcome
Timeframe: Baseline to Endpoint (13 weeks)Population: ITT population
Endpoint was the last post-baseline non-missing result through Week 13 carried forward.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=215 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=228 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=245 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=235 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=224 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1
Baseline
|
1.188 Liters
Standard Deviation 0.408
|
1.194 Liters
Standard Deviation 0.408
|
1.255 Liters
Standard Deviation 0.408
|
1.175 Liters
Standard Deviation 0.408
|
1.205 Liters
Standard Deviation 0.408
|
|
Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1
Endpoint (Change from Baseline)
|
0.098 Liters
Standard Deviation 0.280
|
0.063 Liters
Standard Deviation 0.280
|
0.028 Liters
Standard Deviation 0.280
|
0.049 Liters
Standard Deviation 0.280
|
-0.003 Liters
Standard Deviation 0.280
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (26 weeks)Population: ITT population
SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), \& total score. Best health scores have a low numeric value. All component scores \& total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=211 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=227 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=240 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=231 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=216 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score
Baseline
|
48.22 Score on a scale
Standard Deviation 17.49
|
47.29 Score on a scale
Standard Deviation 17.49
|
48.27 Score on a scale
Standard Deviation 17.49
|
46.27 Score on a scale
Standard Deviation 17.49
|
46.59 Score on a scale
Standard Deviation 17.49
|
|
Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score
Endpoint (Change from Baseline)
|
-6.04 Score on a scale
Standard Deviation 13.95
|
-7.99 Score on a scale
Standard Deviation 13.95
|
-5.87 Score on a scale
Standard Deviation 13.95
|
-4.93 Score on a scale
Standard Deviation 13.95
|
-2.88 Score on a scale
Standard Deviation 13.95
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (26 weeks)Population: ITT population
Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=213 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=228 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=242 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=234 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=224 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)
Baseline
|
0.24 Proportion of symptom-free nights
Standard Deviation 0.334
|
0.22 Proportion of symptom-free nights
Standard Deviation 0.334
|
0.24 Proportion of symptom-free nights
Standard Deviation 0.334
|
0.25 Proportion of symptom-free nights
Standard Deviation 0.334
|
0.24 Proportion of symptom-free nights
Standard Deviation 0.334
|
|
Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)
Endpoint (Change from Baseline)
|
0.13 Proportion of symptom-free nights
Standard Deviation 0.29
|
0.17 Proportion of symptom-free nights
Standard Deviation 0.29
|
0.16 Proportion of symptom-free nights
Standard Deviation 0.29
|
0.13 Proportion of symptom-free nights
Standard Deviation 0.29
|
0.12 Proportion of symptom-free nights
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Endpoint (26 weeks)Population: ITT population
Partly stable COPD was a composite measure that included the following COPD outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=221 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=235 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=249 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=239 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=232 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Partly Stable COPD
|
91 Participants
|
101 Participants
|
92 Participants
|
98 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Endpoint (26 weeks)Population: ITT population
Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=221 Participants
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=235 Participants
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=249 Participants
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=239 Participants
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=232 Participants
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Mild, Moderate, or Severe COPD Exacerbations
Mild
|
56 Participants
|
53 Participants
|
49 Participants
|
61 Participants
|
64 Participants
|
|
Number of Participants With Mild, Moderate, or Severe COPD Exacerbations
Moderate
|
24 Participants
|
20 Participants
|
29 Participants
|
33 Participants
|
38 Participants
|
|
Number of Participants With Mild, Moderate, or Severe COPD Exacerbations
Severe
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
MF/F MDI 400/10 mcg BID
Serious events: 26 serious events
Other events: 37 other events
Deaths: 0 deaths
MF/F MDI 200/10 mcg BID
Serious events: 28 serious events
Other events: 28 other events
Deaths: 0 deaths
MF MDI 400 mcg BID
Serious events: 33 serious events
Other events: 34 other events
Deaths: 0 deaths
F MDI 10 mcg BID
Serious events: 25 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 21 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MF/F MDI 400/10 mcg BID
n=225 participants at risk
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=239 participants at risk
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=253 participants at risk
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=243 participants at risk
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=236 participants at risk
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Cardio failure acute
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Cor pulmonale
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
1.3%
3/239 • Number of events 3
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.79%
2/253 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.82%
2/243 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Eye disorders
Cataract
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.84%
2/239 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
1.2%
3/253 • Number of events 3
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Eye disorders
Glaucoma
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Eye disorders
Lenticular opacities
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.84%
2/239 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.79%
2/253 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Gastric atrophic
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
General disorders
Death
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
General disorders
Sudden death
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
H1N1 influenza
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Lobar pneumonia
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Pneumonia
|
2.2%
5/225 • Number of events 6
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
1.6%
4/253 • Number of events 5
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
1.6%
4/243 • Number of events 5
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Pumonary tuberculosis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Rectal abcess
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Sepsis
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Viral infection
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Investigations
Intraocular pressure increased
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Amnesia
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/236 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.40%
1/253 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Psychiatric disorders
Depression
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Renal and urinary disorders
Renal failure
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.3%
12/225 • Number of events 12
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.3%
8/239 • Number of events 10
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
4.7%
12/253 • Number of events 14
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.7%
9/243 • Number of events 10
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
5.5%
13/236 • Number of events 14
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
2/225 • Number of events 2
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.41%
1/243 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/225 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/239
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/225
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.42%
1/239 • Number of events 1
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/253
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/243
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
0.00%
0/236
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
Other adverse events
| Measure |
MF/F MDI 400/10 mcg BID
n=225 participants at risk
Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
|
MF/F MDI 200/10 mcg BID
n=239 participants at risk
MF/F 200/10 mcg via a MDI BID for 52 weeks.
|
MF MDI 400 mcg BID
n=253 participants at risk
Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
|
F MDI 10 mcg BID
n=243 participants at risk
Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
|
Placebo
n=236 participants at risk
Placebo MDI BID for 26 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.8%
13/225 • Number of events 16
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.8%
9/239 • Number of events 11
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
5.5%
14/253 • Number of events 21
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
4.9%
12/243 • Number of events 13
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.8%
9/236 • Number of events 11
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
18/225 • Number of events 20
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.3%
8/239 • Number of events 12
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
3.2%
8/253 • Number of events 10
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
4.1%
10/243 • Number of events 13
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
4.7%
11/236 • Number of events 13
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
|
Nervous system disorders
Headache
|
4.0%
9/225 • Number of events 16
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
5.0%
12/239 • Number of events 24
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
6.3%
16/253 • Number of events 21
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
4.5%
11/243 • Number of events 29
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
5.9%
14/236 • Number of events 20
Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to publish or publicly present results. The investigator agrees not to publish or publicly present any interim results without prior written consent of the sponsor. The investigator agrees to provide to the sponsor 45 days before submission for publication that report results of the study. The sponsor shall have the right to review \& comment with respect to publications, abstracts, slides, \& manuscripts \& the right to review \& comment on the data \& presentation.
- Publication restrictions are in place
Restriction type: OTHER