Trial Outcomes & Findings for Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 ) (NCT NCT00968201)
NCT ID: NCT00968201
Last Updated: 2022-02-03
Results Overview
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
689 participants
Primary outcome timeframe
12 weeks of treatment
Results posted on
2022-02-03
Participant Flow
Base Study: 93 sites in the United States (US) and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Dec-1997 to Mar-1999. Extension Study: 75 sites in the US and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Mar-1998 to Mar-2001.
Base Study: Patients who required excluded medication and those who did not meet a minimum predefined level of asthma symptoms and β-agonist use during run-in (Period I) were excluded from randomization (Period II). Extension Study (Period III): Patients who did not complete Visit 9 of Base Study were not eligible for the optional Extension.
Participant milestones
| Measure |
Placebo
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Usual Care
"Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III.
|
Montelukast
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
|
|---|---|---|---|
|
Base Study - (Period II)
STARTED
|
228
|
0
|
461
|
|
Base Study - (Period II)
COMPLETED
|
202
|
0
|
416
|
|
Base Study - (Period II)
NOT COMPLETED
|
26
|
0
|
45
|
|
Extension Study - (Period III)
STARTED
|
0
|
157
|
364
|
|
Extension Study - (Period III)
COMPLETED
|
0
|
33
|
84
|
|
Extension Study - (Period III)
NOT COMPLETED
|
0
|
124
|
280
|
Reasons for withdrawal
| Measure |
Placebo
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Usual Care
"Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III.
|
Montelukast
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
|
|---|---|---|---|
|
Base Study - (Period II)
Adverse Event
|
8
|
0
|
16
|
|
Base Study - (Period II)
Lack of Efficacy
|
0
|
0
|
1
|
|
Base Study - (Period II)
Lost to Follow-up
|
2
|
0
|
7
|
|
Base Study - (Period II)
Protocol Violation
|
12
|
0
|
12
|
|
Base Study - (Period II)
Withdrawal by Subject
|
4
|
0
|
8
|
|
Base Study - (Period II)
Site Error
|
0
|
0
|
1
|
|
Extension Study - (Period III)
Adverse Event
|
0
|
5
|
22
|
|
Extension Study - (Period III)
Lost to Follow-up
|
0
|
7
|
13
|
|
Extension Study - (Period III)
Protocol Violation
|
0
|
17
|
14
|
|
Extension Study - (Period III)
Withdrawal by Subject
|
0
|
20
|
40
|
|
Extension Study - (Period III)
Patient Relocated
|
0
|
1
|
1
|
|
Extension Study - (Period III)
Noncompliance
|
0
|
0
|
3
|
|
Extension Study - (Period III)
Other
|
0
|
0
|
2
|
|
Extension Study - (Period III)
Study Terminated for Admin Reasons
|
0
|
74
|
185
|
Baseline Characteristics
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Baseline characteristics by cohort
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
Total
n=689 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.62 years
STANDARD_DEVIATION 1.10 • n=5 Participants
|
3.58 years
STANDARD_DEVIATION 1.11 • n=7 Participants
|
3.59 years
STANDARD_DEVIATION 1.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
With CAEs
|
202 Participants
|
406 Participants
|
|
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
Without CAEs
|
26 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis. Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
With Drug-Related CAEs
|
9 Participants
|
19 Participants
|
|
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
Without Drug-Related CAEs
|
219 Participants
|
442 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis. A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious CAEs Reported by Patients - Base Study
With Serious CAEs
|
9 Participants
|
17 Participants
|
|
Number of Patients With Serious CAEs Reported by Patients - Base Study
Without Serious CAEs
|
219 Participants
|
444 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
Patients who reported serious drug-related CAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
With Serious Drug-related CAEs
|
0 Participants
|
2 Participants
|
|
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
Without Serious Drug-related CAEs
|
228 Participants
|
459 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to CAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to CAEs - Base Study
Discontinued Due to CAEs
|
7 Participants
|
16 Participants
|
|
Number of Patients Who Were Discontinued Due to CAEs - Base Study
Did Not Discontinue Due to CAEs
|
221 Participants
|
445 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
Discontinued Due to Drug-related CAEs
|
1 Participants
|
2 Participants
|
|
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
Did Not Discontinue Due to Drug-related CAEs
|
227 Participants
|
459 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to serious CAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=228 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=461 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
Discontinued Due to Serious CAEs
|
2 Participants
|
8 Participants
|
|
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
Did Not Discontinue Due to Serious CAEs
|
226 Participants
|
453 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=224 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=451 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
With LAEs
|
12 Participants
|
16 Participants
|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
Without LAEs
|
212 Participants
|
435 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Outcome measures
| Measure |
Placebo
n=224 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=451 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
With Drug-Related LAEs
|
1 Participants
|
7 Participants
|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
Without Drug-Related LAEs
|
223 Participants
|
444 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to LAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=224 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=451 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to LAEs - Base Study
Did Not Discontinue Due to LAEs
|
223 Participants
|
451 Participants
|
|
Number of Patients Who Were Discontinued Due to LAEs - Base Study
Discontinued Due to LAEs
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks of treatmentPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=224 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=451 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
Discontinued Due to Drug-related LAEs
|
1 Participants
|
0 Participants
|
|
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
Did Not Discontinue Due to Drug-related LAEs
|
223 Participants
|
451 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
With CAE
|
149 Participants
|
353 Participants
|
|
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
Without CAE
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related CAEs Reported by Patients - Extension
With Drug-related CAEs
|
2 Participants
|
14 Participants
|
|
Number of Patients With Drug-related CAEs Reported by Patients - Extension
Without Drug-related CAEs
|
155 Participants
|
350 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious CAEs Reported by Patients - Extension
With Serious CAEs
|
15 Participants
|
38 Participants
|
|
Number of Patients With Serious CAEs Reported by Patients - Extension
Without Serious CAEs
|
142 Participants
|
326 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients who reported serious drug-related CAEs up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
With Serious Drug-related CAEs
|
0 Participants
|
4 Participants
|
|
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
Without Serious Drug-related CAEs
|
157 Participants
|
360 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to CAEs up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to CAEs - Extension
Discontinued Due to CAEs
|
5 Participants
|
18 Participants
|
|
Number of Patients Who Were Discontinued Due to CAEs - Extension
Did Not Discontinue Due to CAEs
|
152 Participants
|
346 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
Discontinued Due to Drug-related CAEs
|
0 Participants
|
2 Participants
|
|
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
Did Not Discontinue Due to Drug-related CAEs
|
157 Participants
|
362 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
Discontinued Due to Serious CAEs
|
1 Participants
|
9 Participants
|
|
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
Did Not Discontinue Due to Serious CAEs
|
156 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=157 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=364 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
Discontinued Due to Serious Drug-related CAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
Not Discontinued Due to Serious Drug-related CAEs
|
157 Participants
|
363 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication were included in the analysis.
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
With LAEs
|
14 Participants
|
42 Participants
|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
Without LAEs
|
140 Participants
|
315 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
With Drug-related LAEs
|
0 Participants
|
7 Participants
|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Without Drug-related LAEs
|
154 Participants
|
350 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had any laboratory tests performed were included in the analysis.
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious LAEs - Extension
With Serious LAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients With Serious LAEs - Extension
Without Serious LAEs
|
154 Participants
|
356 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who reported serious drug-related LAEs up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
With Serious Drug-Related LAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Without Serious Drug-Related LAEs
|
154 Participants
|
356 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to LAEs up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to LAEs - Extension
Discontinued Due to LAEs
|
0 Participants
|
4 Participants
|
|
Number of Patients Who Were Discontinued Due to LAEs - Extension
Did Not Discontinue Due to LAEs
|
154 Participants
|
353 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
Discontinued Due to Drug-related LAEs
|
0 Participants
|
4 Participants
|
|
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
Did Not Discontinue Due to Drug-related LAEs
|
154 Participants
|
353 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
Discontinued Due to Serious LAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
Did Not Discontinue Due to Serious LAEs
|
154 Participants
|
356 Participants
|
SECONDARY outcome
Timeframe: up to 2.8 yearsPopulation: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment
Outcome measures
| Measure |
Placebo
n=154 Participants
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Montelukast
n=357 Participants
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
Discontinued Due to Serious Drug-related LAEs
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
Not Discontinued Due to Serious Drug-related LAEs
|
154 Participants
|
356 Participants
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 188 other events
Deaths: 0 deaths
Usual Care
Serious events: 15 serious events
Other events: 148 other events
Deaths: 0 deaths
Montelukast
Serious events: 56 serious events
Other events: 435 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=228 participants at risk
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Usual Care
n=157 participants at risk
"Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III.
|
Montelukast
n=461 participants at risk
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Drug Overdose (Period II)
|
1.3%
3/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
1.1%
5/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Injury, poisoning and procedural complications
Drug Overdose (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
2.5%
9/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Viral (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.64%
1/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Pain, Abdominal (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Injury, poisoning and procedural complications
Trauma (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Injury, poisoning and procedural complications
Tachycardia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Appendicitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Gastroenteritis (Period II)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.22%
1/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Gastroenteritis, Infectious (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.55%
2/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Intra-Abdominal (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Thirst (Period II)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.43%
2/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Thirst (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.55%
2/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Vomiting (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Investigations
Alkaline Phosphatase Increased (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Immune system disorders
Allergy (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.64%
1/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Metabolism and nutrition disorders
Dehydration (Period II)
|
0.44%
1/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Metabolism and nutrition disorders
Dehydration (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.55%
2/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Investigations
Hypokalemia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Psychiatric disorders
Bipolar Disorder (Period II)
|
0.44%
1/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Injury, poisoning and procedural complications
Concussion (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Headache (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Hyperkinesia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Hypersomnia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Meningitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Seizure Disorder (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Somnolence (Period II)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.22%
1/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Somnolence (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Tremor (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Period II)
|
2.2%
5/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
2.2%
10/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.1%
8/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
3.6%
13/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchoconstriction (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
1.3%
2/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.55%
2/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.64%
1/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory, Upper (Period II)
|
0.44%
1/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory, Upper (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Infiltrate, Pulmonary (Period II)
|
0.44%
1/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Pneumonia (Period II)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.22%
1/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Pneumonia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
1.9%
3/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.82%
3/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Pneumonia, Bacterial (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.64%
1/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Pneumonia, Viral (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.64%
1/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Skin and subcutaneous tissue disorders
Pallor (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Eyelid (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Eye disorders
Mydriasis (Period II)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.22%
1/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Renal and urinary disorders
Anomaly, Urogenital (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.00%
0/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
0.27%
1/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
Other adverse events
| Measure |
Placebo
n=228 participants at risk
Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
|
Usual Care
n=157 participants at risk
"Usual care," defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some
patients receiving montelukast in Period II were switched to usual care in the Extension Study.
Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the "usual care" treatment group in Period III.
|
Montelukast
n=461 participants at risk
Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at
their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
|
|---|---|---|---|
|
General disorders
Fever (Period II)
|
26.8%
61/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
27.1%
125/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Fever (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
38.2%
60/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
45.1%
164/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Viral (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.9%
25/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.1%
55/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Pain, Abdominal (Period II)
|
9.2%
21/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
11.1%
51/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
General disorders
Pain, Abdominal (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
10.2%
16/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.6%
46/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Injury, poisoning and procedural complications
Trauma (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.4%
10/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.0%
29/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Dental Caries (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.4%
10/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
3.3%
12/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Diarrhea (Period II)
|
7.5%
17/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
9.8%
45/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Diarrhea (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
17.8%
28/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.9%
58/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Gastroenteritis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
4.5%
7/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.8%
21/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Vomiting (Period II)
|
19.7%
45/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
16.3%
75/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Gastrointestinal disorders
Vomiting (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
17.8%
28/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
16.5%
60/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Immune system disorders
Allergy (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
2.5%
4/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.0%
22/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Headache (Period II)
|
7.5%
17/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
7.6%
35/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Nervous system disorders
Headache (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
16.6%
26/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.7%
57/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Period II)
|
36.4%
83/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
28.2%
130/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
61.1%
96/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
59.6%
217/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis (Period II)
|
7.9%
18/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
3.9%
18/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
24.2%
38/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.9%
58/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Nasal (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
7.0%
11/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.2%
30/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (Period II)
|
11.4%
26/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.6%
58/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.3%
24/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
26.6%
97/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
4.5%
7/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.9%
25/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory (Period II)
|
5.7%
13/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
4.1%
19/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
10.2%
16/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.1%
44/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory, Upper (Period II)
|
27.6%
63/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
26.7%
123/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Infection, Respiratory, Upper (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
51.6%
81/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
52.7%
192/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Influenza (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.9%
14/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
11.0%
40/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.1%
8/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.0%
22/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis (Period II)
|
15.4%
35/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
11.7%
54/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
31.8%
50/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
33.0%
120/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Pneumonia (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
4.5%
7/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.8%
21/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis (Period II)
|
6.1%
14/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.9%
27/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
13.4%
21/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.4%
45/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis, Allergic (Period II)
|
7.0%
16/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.2%
24/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis, Allergic (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.3%
13/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
11.0%
40/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea (Period II)
|
3.9%
9/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
7.6%
35/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
10.2%
16/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.8%
32/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
9.6%
15/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
4.4%
16/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis (Period II)
|
7.0%
16/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
7.2%
33/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
27.4%
43/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
26.1%
95/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Tonsillitis (Period II)
|
6.6%
15/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
2.6%
12/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Infections and infestations
Tonsillitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
17.8%
28/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
15.4%
56/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Skin and subcutaneous tissue disorders
Rash (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.1%
8/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.8%
21/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Skin and subcutaneous tissue disorders
Urticaria (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.4%
10/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.8%
32/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Skin and subcutaneous tissue disorders
Varicella (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.7%
20/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
12.4%
45/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Eye disorders
Conjunctivitis (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
5.7%
9/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
8.8%
32/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Ear and labyrinth disorders
Otitis (Period II)
|
3.5%
8/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.3%
29/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Ear and labyrinth disorders
Otitis (Period III)
|
0.00%
0/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
21.0%
33/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
17.0%
62/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Ear and labyrinth disorders
Otitis Media (Period II)
|
7.5%
17/228 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
7.8%
36/461 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Ear and labyrinth disorders
Otitis Media (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
22.3%
35/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
23.1%
84/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
|
Ear and labyrinth disorders
Pain, Ear (Period III)
|
—
0/0 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.4%
10/157 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
6.9%
25/364 • During the 12 week base study (Period II) and 36 month extension study (Period III) and up to and including 14 days after the last dose of study therapy.
Although patient may have had 2 or more clinical adverse experiences, patient is counted only once in a category. The same patient may appear in different categories. Adverse events (AEs) in Period II have 0/0 for Usual Care group because there was no Usual Care group. AEs in Period III have 0/0 for Placebo group because there was no Placebo group.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER