Trial Outcomes & Findings for Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (NCT NCT01892436)
NCT ID: NCT01892436
Last Updated: 2019-06-12
Results Overview
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Results posted on
2019-06-12
Participant Flow
The extension FAS (N=457) comprised all patients enrolled in the extension with at least 1 post baseline efficacy assessment during the extension study. 3 patients signed the ICF but had no efficacy assessments during the extension study and were not included in extension FAS.
Of the 457 patients in the extension FAS, 380 (83.2%) completed 260 weeks of treatment (84.4% in the secukinumab 10 mg/kg-75 mg group, 82.0% in the secukinumab 10 mg/kg-150 mg group, 85.1% in the placebo-secukinumab 75 mg group and 81.3% in the placebo-secukinumab 150 mg group)
Participant milestones
| Measure |
Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
161
|
74
|
75
|
|
Overall Study
COMPLETED
|
124
|
132
|
63
|
61
|
|
Overall Study
NOT COMPLETED
|
23
|
29
|
11
|
14
|
Reasons for withdrawal
| Measure |
Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
15
|
4
|
4
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
2
|
1
|
0
|
|
Overall Study
Technical problems
|
2
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
3
|
|
Overall Study
non-compliance with treatment
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
7
|
6
|
2
|
3
|
Baseline Characteristics
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<65
|
132 Count of Participants
n=5 Participants
|
145 Count of Participants
n=7 Participants
|
72 Count of Participants
n=5 Participants
|
71 Count of Participants
n=4 Participants
|
420 Count of Participants
n=21 Participants
|
|
Age, Customized
>=65
|
15 Count of Participants
n=5 Participants
|
16 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
4 Count of Participants
n=4 Participants
|
37 Count of Participants
n=21 Participants
|
|
Age, Customized
>=75
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=4 Participants
|
2 Count of Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
118 Count of participants
n=5 Participants
|
130 Count of participants
n=7 Participants
|
51 Count of participants
n=5 Participants
|
58 Count of participants
n=4 Participants
|
357 Count of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Count of participants
n=5 Participants
|
1 Count of participants
n=7 Participants
|
0 Count of participants
n=5 Participants
|
0 Count of participants
n=4 Participants
|
2 Count of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
27 Count of participants
n=5 Participants
|
29 Count of participants
n=7 Participants
|
23 Count of participants
n=5 Participants
|
16 Count of participants
n=4 Participants
|
95 Count of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Count of participants
n=5 Participants
|
1 Count of participants
n=7 Participants
|
0 Count of participants
n=5 Participants
|
1 Count of participants
n=4 Participants
|
3 Count of participants
n=21 Participants
|
PRIMARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension Full Analysis Set (extension FAS) is comprised all patients enrolled in the extension study who had at least one post baseline assessment of efficacy during the extension period. Patients were analyzed according to the treatment they were assigned.
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 116
|
71.3 percentage of participants
Interval 63.1 to 78.4
|
73.9 percentage of participants
Interval 66.0 to 80.5
|
73.2 percentage of participants
Interval 61.2 to 82.7
|
73.6 percentage of participants
Interval 61.7 to 83.0
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 128
|
69.7 percentage of participants
Interval 61.4 to 77.0
|
72.9 percentage of participants
Interval 65.1 to 79.6
|
76.8 percentage of participants
Interval 64.8 to 85.8
|
74.6 percentage of participants
Interval 62.7 to 83.9
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 140
|
69.8 percentage of participants
Interval 61.3 to 77.1
|
71.1 percentage of participants
Interval 63.1 to 78.0
|
79.2 percentage of participants
Interval 67.7 to 87.5
|
69.4 percentage of participants
Interval 57.3 to 79.5
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 156
|
64.3 percentage of participants
Interval 55.8 to 72.0
|
76.1 percentage of participants
Interval 68.5 to 82.4
|
75.3 percentage of participants
Interval 63.6 to 84.4
|
67.6 percentage of participants
Interval 55.6 to 77.7
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 180
|
73.0 percentage of participants
Interval 64.6 to 80.0
|
72.5 percentage of participants
Interval 64.1 to 79.6
|
74.6 percentage of participants
Interval 62.3 to 84.1
|
67.7 percentage of participants
Interval 54.8 to 78.5
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 208
|
72.8 percentage of participants
Interval 64.4 to 79.9
|
66.9 percentage of participants
Interval 58.5 to 74.3
|
75.0 percentage of participants
Interval 62.8 to 84.4
|
68.2 percentage of participants
Interval 55.4 to 78.8
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 232
|
79.5 percentage of participants
Interval 71.3 to 86.0
|
69.5 percentage of participants
Interval 60.7 to 77.0
|
83.3 percentage of participants
Interval 71.7 to 91.0
|
80.3 percentage of participants
Interval 67.8 to 89.0
|
|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
week 260
|
77.2 percentage of participants
Interval 68.7 to 83.9
|
67.9 percentage of participants
Interval 59.1 to 75.7
|
78.8 percentage of participants
Interval 66.7 to 87.5
|
77.4 percentage of participants
Interval 64.7 to 86.7
|
PRIMARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Proportion of Subjects Who Reached ACR50
week 128
|
43.7 percentage of participants
Interval 35.4 to 52.2
|
52.9 percentage of participants
Interval 44.8 to 60.9
|
56.5 percentage of participants
Interval 44.1 to 68.2
|
53.5 percentage of participants
Interval 41.4 to 65.3
|
|
Proportion of Subjects Who Reached ACR50
week 116
|
43.4 percentage of participants
Interval 35.2 to 51.9
|
51.0 percentage of participants
Interval 42.8 to 59.1
|
49.3 percentage of participants
Interval 37.3 to 61.3
|
47.2 percentage of participants
Interval 35.5 to 59.3
|
|
Proportion of Subjects Who Reached ACR50
week 140
|
41.7 percentage of participants
Interval 33.5 to 50.4
|
48.7 percentage of participants
Interval 40.5 to 56.9
|
51.4 percentage of participants
Interval 39.4 to 63.2
|
44.4 percentage of participants
Interval 32.9 to 56.6
|
|
Proportion of Subjects Who Reached ACR50
week 156
|
39.2 percentage of participants
Interval 31.2 to 47.7
|
56.1 percentage of participants
Interval 47.9 to 64.0
|
52.1 percentage of participants
Interval 40.1 to 63.8
|
47.3 percentage of participants
Interval 35.7 to 59.2
|
|
Proportion of Subjects Who Reached ACR50
week 180
|
43.1 percentage of participants
Interval 34.7 to 51.8
|
45.7 percentage of participants
Interval 37.2 to 54.3
|
52.2 percentage of participants
Interval 39.8 to 64.4
|
50.8 percentage of participants
Interval 38.2 to 63.3
|
|
Proportion of Subjects Who Reached ACR50
week 208
|
44.9 percentage of participants
Interval 36.4 to 53.6
|
46.9 percentage of participants
Interval 38.6 to 55.3
|
52.9 percentage of participants
Interval 40.5 to 65.0
|
53.0 percentage of participants
Interval 40.4 to 65.3
|
|
Proportion of Subjects Who Reached ACR50
week 232
|
49.6 percentage of participants
Interval 40.7 to 58.6
|
53.4 percentage of participants
Interval 44.5 to 62.1
|
53.0 percentage of participants
Interval 40.4 to 65.3
|
50.8 percentage of participants
Interval 37.8 to 63.7
|
|
Proportion of Subjects Who Reached ACR50
week 260
|
51.2 percentage of participants
Interval 42.2 to 60.1
|
52.7 percentage of participants
Interval 43.8 to 61.4
|
60.6 percentage of participants
Interval 47.8 to 72.2
|
50.0 percentage of participants
Interval 37.2 to 62.8
|
PRIMARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Proportion of Subjects Who Reached ACR70
week 116
|
23.8 percentage of participants
Interval 17.2 to 31.8
|
30.1 percentage of participants
Interval 23.1 to 38.1
|
28.2 percentage of participants
Interval 18.4 to 40.3
|
29.2 percentage of participants
Interval 19.3 to 41.2
|
|
Proportion of Subjects Who Reached ACR70
week 128
|
24.6 percentage of participants
Interval 18.0 to 32.7
|
31.0 percentage of participants
Interval 23.9 to 39.0
|
34.8 percentage of participants
Interval 24.0 to 47.3
|
23.9 percentage of participants
Interval 14.9 to 35.8
|
|
Proportion of Subjects Who Reached ACR70
week 140
|
27.3 percentage of participants
Interval 20.3 to 35.7
|
28.3 percentage of participants
Interval 21.4 to 36.3
|
33.3 percentage of participants
Interval 22.9 to 45.5
|
27.8 percentage of participants
Interval 18.2 to 39.8
|
|
Proportion of Subjects Who Reached ACR70
week 156
|
25.9 percentage of participants
Interval 19.1 to 34.0
|
32.9 percentage of participants
Interval 25.7 to 41.0
|
26.0 percentage of participants
Interval 16.8 to 37.8
|
27.0 percentage of participants
Interval 17.7 to 38.8
|
|
Proportion of Subjects Who Reached ACR70
week 180
|
27.0 percentage of participants
Interval 20.0 to 35.4
|
31.2 percentage of participants
Interval 23.7 to 39.7
|
31.3 percentage of participants
Interval 20.9 to 44.0
|
27.7 percentage of participants
Interval 17.7 to 40.4
|
|
Proportion of Subjects Who Reached ACR70
week 208
|
25.7 percentage of participants
Interval 18.8 to 34.1
|
31.0 percentage of participants
Interval 23.8 to 39.3
|
32.4 percentage of participants
Interval 21.8 to 44.9
|
28.8 percentage of participants
Interval 18.6 to 41.4
|
|
Proportion of Subjects Who Reached ACR70
week 232
|
35.4 percentage of participants
Interval 27.3 to 44.5
|
32.1 percentage of participants
Interval 24.3 to 40.9
|
37.9 percentage of participants
Interval 26.5 to 50.7
|
34.4 percentage of participants
Interval 23.0 to 47.8
|
|
Proportion of Subjects Who Reached ACR70
week 260
|
33.9 percentage of participants
Interval 25.9 to 42.9
|
37.4 percentage of participants
Interval 29.2 to 46.3
|
37.9 percentage of participants
Interval 26.5 to 50.7
|
33.9 percentage of participants
Interval 22.6 to 47.1
|
SECONDARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 116
|
-0.4537 change in scores
Standard Deviation 0.60617
|
-0.4592 change in scores
Standard Deviation 0.56155
|
-0.5642 change in scores
Standard Deviation 0.56722
|
-0.4115 change in scores
Standard Deviation 0.66721
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 128
|
-0.4171 change in scores
Standard Deviation 0.61192
|
-0.4619 change in scores
Standard Deviation 0.55835
|
-0.5143 change in scores
Standard Deviation 0.55599
|
-0.3750 change in scores
Standard Deviation 0.69661
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 140
|
-0.4448 change in scores
Standard Deviation 0.61406
|
-0.4713 change in scores
Standard Deviation 0.58791
|
-0.4635 change in scores
Standard Deviation 0.56037
|
-0.3507 change in scores
Standard Deviation 0.69221
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 156
|
-0.4236 change in scores
Standard Deviation 0.61896
|
-0.4266 change in scores
Standard Deviation 0.57491
|
-0.5068 change in scores
Standard Deviation 0.62548
|
-0.3159 change in scores
Standard Deviation 0.73507
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 180
|
-0.4617 change in scores
Standard Deviation 0.61472
|
-0.4305 change in scores
Standard Deviation 0.59901
|
-0.5698 change in scores
Standard Deviation 0.65258
|
-0.3538 change in scores
Standard Deviation 0.71246
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 208
|
-0.4463 change in scores
Standard Deviation 0.57130
|
-0.3857 change in scores
Standard Deviation 0.59304
|
-0.5531 change in scores
Standard Deviation 0.62622
|
-0.3447 change in scores
Standard Deviation 0.74745
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 232
|
-0.4710 change in scores
Standard Deviation 0.60931
|
-0.4122 change in scores
Standard Deviation 0.60461
|
-0.5777 change in scores
Standard Deviation 0.66930
|
-0.3952 change in scores
Standard Deviation 0.72115
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 260
|
-0.4821 change in scores
Standard Deviation 0.61170
|
-0.4036 change in scores
Standard Deviation 0.58334
|
-0.5038 change in scores
Standard Deviation 0.61039
|
-0.3730 change in scores
Standard Deviation 0.71306
|
SECONDARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 260
|
55.6 percentage of participants
Interval 46.5 to 64.3
|
48.9 percentage of participants
Interval 40.1 to 57.7
|
59.1 percentage of participants
Interval 46.3 to 70.8
|
53.2 percentage of participants
Interval 40.2 to 65.8
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 116
|
53.1 percentage of participants
Interval 44.6 to 61.5
|
52.3 percentage of participants
Interval 44.1 to 60.4
|
63.9 percentage of participants
Interval 51.7 to 74.6
|
50.0 percentage of participants
Interval 38.1 to 61.9
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 128
|
52.8 percentage of participants
Interval 44.3 to 61.2
|
51.9 percentage of participants
Interval 43.8 to 60.0
|
57.1 percentage of participants
Interval 44.8 to 68.7
|
54.9 percentage of participants
Interval 42.7 to 66.6
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 140
|
55.4 percentage of participants
Interval 46.7 to 63.7
|
52.3 percentage of participants
Interval 44.1 to 60.4
|
56.9 percentage of participants
Interval 44.8 to 68.4
|
48.6 percentage of participants
Interval 36.8 to 60.6
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 156
|
52.8 percentage of participants
Interval 44.3 to 61.1
|
52.3 percentage of participants
Interval 44.1 to 60.3
|
60.8 percentage of participants
Interval 48.7 to 71.7
|
44.6 percentage of participants
Interval 33.2 to 56.6
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 180
|
56.9 percentage of participants
Interval 48.2 to 65.3
|
51.5 percentage of participants
Interval 42.8 to 60.1
|
61.2 percentage of participants
Interval 48.5 to 72.6
|
47.7 percentage of participants
Interval 35.3 to 60.4
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 208
|
53.3 percentage of participants
Interval 44.6 to 61.9
|
50.0 percentage of participants
Interval 41.6 to 58.4
|
59.4 percentage of participants
Interval 46.9 to 70.9
|
48.5 percentage of participants
Interval 36.1 to 61.0
|
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
week 232
|
55.2 percentage of participants
Interval 46.1 to 64.0
|
48.9 percentage of participants
Interval 40.1 to 57.7
|
59.1 percentage of participants
Interval 46.3 to 70.8
|
52.5 percentage of participants
Interval 39.4 to 65.2
|
SECONDARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56\*TJC28\^0.5 + 0.28\*SJC28\^0.5 + 0.36\*ln(CRP+1) + 0.014\*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP \< 2.6 Low disease activity is defined as DAS28-CRP \< 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 116
|
-2.044 change in scores
Standard Deviation 1.3382
|
-1.904 change in scores
Standard Deviation 1.3165
|
-2.282 change in scores
Standard Deviation 1.2732
|
-1.853 change in scores
Standard Deviation 1.2737
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 128
|
-2.013 change in scores
Standard Deviation 1.3446
|
-1.962 change in scores
Standard Deviation 1.2900
|
-2.333 change in scores
Standard Deviation 1.2815
|
-2.031 change in scores
Standard Deviation 1.3290
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 140
|
-2.074 change in scores
Standard Deviation 1.3224
|
-1.912 change in scores
Standard Deviation 1.2246
|
-2.412 change in scores
Standard Deviation 1.3059
|
-1.830 change in scores
Standard Deviation 1.3136
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 156
|
-1.844 change in scores
Standard Deviation 1.4923
|
-1.942 change in scores
Standard Deviation 1.3195
|
-2.109 change in scores
Standard Deviation 1.3188
|
-1.743 change in scores
Standard Deviation 1.3630
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 180
|
-2.058 change in scores
Standard Deviation 1.3760
|
-1.937 change in scores
Standard Deviation 1.2674
|
-2.327 change in scores
Standard Deviation 1.2339
|
-1.867 change in scores
Standard Deviation 1.4590
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 208
|
-2.042 change in scores
Standard Deviation 1.2907
|
-1.767 change in scores
Standard Deviation 1.4574
|
-2.344 change in scores
Standard Deviation 1.3351
|
-1.862 change in scores
Standard Deviation 1.4708
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 232
|
-2.225 change in scores
Standard Deviation 1.2570
|
-2.046 change in scores
Standard Deviation 1.2590
|
-2.611 change in scores
Standard Deviation 1.3247
|
-2.286 change in scores
Standard Deviation 1.2102
|
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
week 260
|
-2.112 change in scores
Standard Deviation 1.2664
|
-2.074 change in scores
Standard Deviation 1.3146
|
-2.506 change in scores
Standard Deviation 1.3774
|
-2.099 change in scores
Standard Deviation 1.2466
|
SECONDARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Population: Extension FAS
Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Low Disease Activity
week 116
|
70.3 percentage of participants
Interval 62.1 to 77.5
|
64.7 percentage of participants
Interval 56.5 to 72.1
|
70.4 percentage of participants
Interval 58.2 to 80.4
|
63.9 percentage of participants
Interval 51.7 to 74.6
|
|
Percentage of Subjects Achieving Low Disease Activity
week 128
|
69.5 percentage of participants
Interval 61.1 to 76.8
|
69.9 percentage of participants
Interval 61.9 to 76.8
|
75.4 percentage of participants
Interval 63.3 to 84.6
|
68.6 percentage of participants
Interval 56.2 to 78.9
|
|
Percentage of Subjects Achieving Low Disease Activity
week 140
|
72.9 percentage of participants
Interval 64.6 to 79.9
|
66.0 percentage of participants
Interval 57.8 to 73.4
|
75.0 percentage of participants
Interval 63.2 to 84.1
|
65.3 percentage of participants
Interval 53.1 to 75.9
|
|
Percentage of Subjects Achieving Low Disease Activity
week 156
|
63.4 percentage of participants
Interval 54.8 to 71.2
|
67.9 percentage of participants
Interval 59.9 to 75.1
|
61.6 percentage of participants
Interval 49.5 to 72.6
|
58.9 percentage of participants
Interval 46.8 to 70.1
|
|
Percentage of Subjects Achieving Low Disease Activity
week 180
|
71.2 percentage of participants
Interval 62.8 to 78.4
|
70.1 percentage of participants
Interval 61.6 to 77.4
|
65.7 percentage of participants
Interval 53.0 to 76.6
|
68.8 percentage of participants
Interval 55.8 to 79.4
|
|
Percentage of Subjects Achieving Low Disease Activity
week 208
|
71.7 percentage of participants
Interval 63.3 to 78.9
|
65.8 percentage of participants
Interval 57.4 to 73.3
|
67.2 percentage of participants
Interval 54.5 to 77.9
|
71.2 percentage of participants
Interval 58.6 to 81.4
|
|
Percentage of Subjects Achieving Low Disease Activity
week 232
|
75.2 percentage of participants
Interval 66.7 to 82.2
|
73.5 percentage of participants
Interval 65.0 to 80.6
|
79.4 percentage of participants
Interval 67.0 to 88.1
|
84.7 percentage of participants
Interval 72.5 to 92.4
|
|
Percentage of Subjects Achieving Low Disease Activity
week 260
|
74.4 percentage of participants
Interval 65.8 to 81.5
|
75.0 percentage of participants
Interval 66.6 to 81.9
|
76.9 percentage of participants
Interval 64.5 to 86.1
|
77.4 percentage of participants
Interval 64.7 to 86.7
|
SECONDARY outcome
Timeframe: weeks 116, 128, 140, 156, 180, 208, 232 and 260Percentage of subjects achieving disease remission (DAS28\<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
Outcome measures
| Measure |
Secukinumab 75mg
n=147 Participants
Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab 150mg
n=161 Participants
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Placebo - AIN457A 75mg
n=74 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Placebo - AIN457 150mg
n=75 Participants
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 116
|
52.4 percentage of participants
Interval 44.0 to 60.7
|
50.3 percentage of participants
Interval 42.2 to 58.5
|
47.9 percentage of participants
Interval 36.0 to 60.0
|
45.8 percentage of participants
Interval 34.2 to 57.9
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 128
|
54.6 percentage of participants
Interval 46.0 to 62.9
|
49.4 percentage of participants
Interval 41.3 to 57.4
|
55.1 percentage of participants
Interval 42.7 to 66.9
|
57.1 percentage of participants
Interval 44.8 to 68.7
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 140
|
58.6 percentage of participants
Interval 49.9 to 66.7
|
46.7 percentage of participants
Interval 38.5 to 55.0
|
55.6 percentage of participants
Interval 43.4 to 67.1
|
51.4 percentage of participants
Interval 39.4 to 63.2
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 156
|
48.6 percentage of participants
Interval 40.2 to 57.1
|
52.6 percentage of participants
Interval 44.4 to 60.6
|
43.8 percentage of participants
Interval 32.4 to 55.9
|
46.6 percentage of participants
Interval 35.0 to 58.6
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 180
|
54.7 percentage of participants
Interval 46.0 to 63.1
|
53.3 percentage of participants
Interval 44.6 to 61.8
|
49.3 percentage of participants
Interval 37.0 to 61.6
|
58.6 percentage of participants
Interval 46.2 to 70.0
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 208
|
56.5 percentage of participants
Interval 47.8 to 64.8
|
52.1 percentage of participants
Interval 43.7 to 60.3
|
55.2 percentage of participants
Interval 42.6 to 67.2
|
53.0 percentage of participants
Interval 40.4 to 65.3
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 232
|
64.3 percentage of participants
Interval 55.4 to 72.4
|
61.4 percentage of participants
Interval 52.5 to 69.6
|
65.1 percentage of participants
Interval 51.9 to 76.4
|
69.5 percentage of participants
Interval 56.0 to 80.5
|
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
week 260
|
55.0 percentage of participants
Interval 46.0 to 63.7
|
58.3 percentage of participants
Interval 49.4 to 66.7
|
64.6 percentage of participants
Interval 51.7 to 75.8
|
66.1 percentage of participants
Interval 52.9 to 77.4
|
Adverse Events
Any AIN457 75 mg
Serious events: 48 serious events
Other events: 197 other events
Deaths: 3 deaths
Any AIN457 150 mg
Serious events: 96 serious events
Other events: 264 other events
Deaths: 3 deaths
Any AIN457 300 mg
Serious events: 10 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any AIN457 75 mg
n=292 participants at risk
Any AIN457 75 mg
|
Any AIN457 150 mg
n=473 participants at risk
Any AIN457 150 mg
|
Any AIN457 300 mg
n=165 participants at risk
Any AIN457 300 mg
|
Placebo
n=202 participants at risk
Placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Angina pectoris
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Angina unstable
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
4/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
3/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Palpitations
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Endocrine disorders
Goitre
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Eye disorders
Ocular myasthenia
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Crohn's disease
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Enteritis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Oesophagitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
General disorders
Impaired healing
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.85%
4/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
General disorders
Peripheral swelling
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
General disorders
Pyrexia
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Abdominal sepsis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Abscess limb
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Appendiceal abscess
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Appendicitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Cellulitis
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.85%
4/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Dengue fever
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.63%
3/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Erysipelas
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Lung abscess
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Necrotising fasciitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Pneumonia
|
1.0%
3/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.85%
4/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Prostatitis Escherichia coli
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Rash pustular
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Sepsis
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Septic shock
|
0.68%
2/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Sinusitis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Tonsillitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Urosepsis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Viral infection
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Periprosthetic osteolysis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.63%
3/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Limb asymmetry
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
3/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.5%
7/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.1%
5/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of pharynx
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Dizziness
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Hemiplegia
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Presyncope
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Syncope
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Thrombotic stroke
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Transient ischaemic attack
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Psychiatric disorders
Depression
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Renal and urinary disorders
Acute kidney injury
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.42%
2/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.63%
3/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Hypertension
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.21%
1/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Polyarteritis nodosa
|
0.34%
1/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
Other adverse events
| Measure |
Any AIN457 75 mg
n=292 participants at risk
Any AIN457 75 mg
|
Any AIN457 150 mg
n=473 participants at risk
Any AIN457 150 mg
|
Any AIN457 300 mg
n=165 participants at risk
Any AIN457 300 mg
|
Placebo
n=202 participants at risk
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
23/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
8.0%
38/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
3.0%
6/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Nausea
|
5.8%
17/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
3.0%
14/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.8%
3/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.99%
2/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
15/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.7%
8/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Bronchitis
|
8.2%
24/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
7.4%
35/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.5%
9/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
3.0%
6/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Gastroenteritis
|
3.4%
10/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
6.3%
30/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.2%
2/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.99%
2/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Nasopharyngitis
|
24.0%
70/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
21.4%
101/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
8.5%
14/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.4%
11/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Pharyngitis
|
5.1%
15/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
4.7%
22/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.00%
0/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Sinusitis
|
5.8%
17/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.5%
26/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.8%
3/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
2.0%
4/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Upper respiratory tract infection
|
21.2%
62/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
19.2%
91/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
6.1%
10/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.9%
12/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Infections and infestations
Urinary tract infection
|
7.2%
21/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.7%
27/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.2%
2/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.99%
2/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
24/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
6.3%
30/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.8%
3/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.5%
3/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
30/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
7.0%
33/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.8%
3/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.99%
2/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
7.9%
23/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
5.7%
27/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.2%
2/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.99%
2/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Nervous system disorders
Headache
|
10.6%
31/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
8.9%
42/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
3.5%
7/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
21/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
6.3%
30/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.8%
3/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
3.0%
6/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
20/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
4.0%
19/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.61%
1/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
2.0%
4/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.9%
23/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
4.9%
23/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
1.2%
2/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
0.50%
1/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
|
Vascular disorders
Hypertension
|
9.2%
27/292 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
7.0%
33/473 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
4.2%
7/165 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
2.5%
5/202 • week 260
Safety analysis is based on the actual dose received. Pts who escalated from 75mg to 150mg or 300mg are also analyzed at the escalated dose Any AIN75: 202 AIN75 + 93 PBO-AIN150 - 3 PBO-AIN150 (re-randomized but not exposed) = 292 Any AIN150: 202 AIN150 + 94 PBO-AIN150 + 178 Up-titrators from 75mg -1 PBO-AIN150 (re-randomized but not exposed) = 473 Any 300: 165 Up-titrators Placebo: 149 pts entered the extension and were on PBO up to wks 16/24. Also, add 53 PBOs who did not enter the extension
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: +1 (862) 778-8300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER