Trial Outcomes & Findings for VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients (NCT NCT00561925)
NCT ID: NCT00561925
Last Updated: 2014-04-07
Results Overview
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1068 participants
Primary outcome timeframe
week 48
Results posted on
2014-04-07
Participant Flow
Participant milestones
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg given once daily
|
NVP IR 200mg BID
Nevirapine immediate release 200 mg given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg given once daily
|
NVP XR
|
NVP IR to XR
|
|---|---|---|---|---|---|
|
14 Day Lead-In Period
NOT COMPLETED
|
55
|
0
|
0
|
0
|
0
|
|
144-week Double-blind, Double-dummy
STARTED
|
0
|
508
|
505
|
0
|
0
|
|
14 Day Lead-In Period
STARTED
|
1068
|
0
|
0
|
0
|
0
|
|
14 Day Lead-In Period
COMPLETED
|
1013
|
0
|
0
|
0
|
0
|
|
144-week Double-blind, Double-dummy
COMPLETED
|
0
|
358
|
378
|
0
|
0
|
|
144-week Double-blind, Double-dummy
NOT COMPLETED
|
0
|
150
|
127
|
0
|
0
|
|
Open-Label Extension Period
STARTED
|
0
|
1
|
0
|
358
|
378
|
|
Open-Label Extension Period
COMPLETED
|
0
|
1
|
0
|
315
|
328
|
|
Open-Label Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
43
|
50
|
Reasons for withdrawal
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg given once daily
|
NVP IR 200mg BID
Nevirapine immediate release 200 mg given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg given once daily
|
NVP XR
|
NVP IR to XR
|
|---|---|---|---|---|---|
|
14 Day Lead-In Period
Adverse Event
|
38
|
0
|
0
|
0
|
0
|
|
14 Day Lead-In Period
In/Exclusion criteria
|
4
|
0
|
0
|
0
|
0
|
|
14 Day Lead-In Period
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
|
14 Day Lead-In Period
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
0
|
|
14 Day Lead-In Period
Other
|
5
|
0
|
0
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Adverse Event
|
0
|
48
|
43
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Protocol Violation
|
0
|
15
|
9
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Lost to Follow-up
|
0
|
15
|
12
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Withdrawal by Subject
|
0
|
19
|
7
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Lack of Efficacy
|
0
|
36
|
33
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Pregnancy
|
0
|
1
|
9
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Death
|
0
|
6
|
3
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Not treated with study drug
|
0
|
2
|
0
|
0
|
0
|
|
144-week Double-blind, Double-dummy
Other
|
0
|
8
|
11
|
0
|
0
|
|
Open-Label Extension Period
Declined entry into extension period
|
0
|
0
|
0
|
43
|
50
|
Baseline Characteristics
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
Baseline characteristics by cohort
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=508 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
Total
n=1013 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
—
|
38.0 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Age, Customized
18 to < 41 years
|
—
|
316 participants
n=7 Participants
|
299 participants
n=5 Participants
|
615 participants
n=4 Participants
|
|
Age, Customized
41 to < 56 years
|
—
|
165 participants
n=7 Participants
|
182 participants
n=5 Participants
|
347 participants
n=4 Participants
|
|
Age, Customized
56 to < 65 years
|
—
|
25 participants
n=7 Participants
|
19 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Age, Customized
65 years or more
|
—
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Gender
Female
|
—
|
75 participants
n=7 Participants
|
74 participants
n=5 Participants
|
149 participants
n=4 Participants
|
|
Gender
Male
|
—
|
433 participants
n=7 Participants
|
431 participants
n=5 Participants
|
864 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native
|
—
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
—
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
—
|
113 participants
n=7 Participants
|
94 participants
n=5 Participants
|
207 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hawaiian / Pacific Isle.
|
—
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
—
|
376 participants
n=7 Participants
|
387 participants
n=5 Participants
|
763 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
—
|
109 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic / Latino
|
—
|
399 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
789 Participants
n=4 Participants
|
|
Region of Enrollment
North America / Australia
|
—
|
149 participants
n=7 Participants
|
141 participants
n=5 Participants
|
290 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
—
|
253 participants
n=7 Participants
|
257 participants
n=5 Participants
|
510 participants
n=4 Participants
|
|
Region of Enrollment
Latin America
|
—
|
49 participants
n=7 Participants
|
58 participants
n=5 Participants
|
107 participants
n=4 Participants
|
|
Region of Enrollment
Africa
|
—
|
57 participants
n=7 Participants
|
49 participants
n=5 Participants
|
106 participants
n=4 Participants
|
|
Smoking History
Never smoked
|
—
|
250 participants
n=7 Participants
|
224 participants
n=5 Participants
|
474 participants
n=4 Participants
|
|
Smoking History
Ex-smoker
|
—
|
81 participants
n=7 Participants
|
86 participants
n=5 Participants
|
167 participants
n=4 Participants
|
|
Smoking History
Current smoker
|
—
|
177 participants
n=7 Participants
|
195 participants
n=5 Participants
|
372 participants
n=4 Participants
|
|
Alcohol Status
Non drinker
|
—
|
151 participants
n=7 Participants
|
168 participants
n=5 Participants
|
319 participants
n=4 Participants
|
|
Alcohol Status
Drinks - no interfere with trial
|
—
|
354 participants
n=7 Participants
|
335 participants
n=5 Participants
|
689 participants
n=4 Participants
|
|
Alcohol Status
Drinks - could interfere with trial
|
—
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 48Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
—
|
384 participants
|
409 participants
|
—
|
|
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
—
|
122 participants
|
96 participants
|
—
|
SECONDARY outcome
Timeframe: week 0 to 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 0 to <2
|
—
|
1 proportion of participants
|
1 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 2 to <4
|
—
|
0.84 proportion of participants
|
0.865 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 4 to <6
|
—
|
0.838 proportion of participants
|
0.865 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 6 to <8
|
—
|
0.834 proportion of participants
|
0.865 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 8 to <12
|
—
|
0.834 proportion of participants
|
0.863 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 12 to <16
|
—
|
0.832 proportion of participants
|
0.861 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 16 to <24
|
—
|
0.83 proportion of participants
|
0.859 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 24 to <32
|
—
|
0.822 proportion of participants
|
0.848 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 32 to <40
|
—
|
0.806 proportion of participants
|
0.832 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 40 to <48
|
—
|
0.792 proportion of participants
|
0.816 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 48 to <60
|
—
|
0.777 proportion of participants
|
0.808 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 60 to <72
|
—
|
0.759 proportion of participants
|
0.788 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 72 to <84
|
—
|
0.733 proportion of participants
|
0.766 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 84 to <96
|
—
|
0.713 proportion of participants
|
0.745 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 96 to <108
|
—
|
0.686 proportion of participants
|
0.719 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 108 to <120
|
—
|
0.662 proportion of participants
|
0.697 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 120 to <132
|
—
|
0.65 proportion of participants
|
0.681 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 132 to <144
|
—
|
0.63 proportion of participants
|
0.671 proportion of participants
|
—
|
|
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Interval Week 144 to <168
|
—
|
0.61 proportion of participants
|
0.66 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Responder
|
—
|
296 participants
|
321 participants
|
—
|
|
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Non responder
|
—
|
210 participants
|
184 participants
|
—
|
SECONDARY outcome
Timeframe: week 0 to 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 0 to <2
|
—
|
0 proportion of participants
|
0 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 2 to <4
|
—
|
0.006 proportion of participants
|
0.002 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 4 to <6
|
—
|
0.006 proportion of participants
|
0.006 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 6 to <8
|
—
|
0.023 proportion of participants
|
0.008 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 8 to <12
|
—
|
0.029 proportion of participants
|
0.01 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 12 to <16
|
—
|
0.029 proportion of participants
|
0.019 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 16 to <24
|
—
|
0.031 proportion of participants
|
0.021 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 24 to <32
|
—
|
0.04 proportion of participants
|
0.025 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 32 to <40
|
—
|
0.042 proportion of participants
|
0.025 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 40 to <48
|
—
|
0.047 proportion of participants
|
0.027 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 48 to <60
|
—
|
0.047 proportion of participants
|
0.027 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 60 to <72
|
—
|
0.052 proportion of participants
|
0.032 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 72 to <84
|
—
|
0.054 proportion of participants
|
0.035 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 84 to <96
|
—
|
0.054 proportion of participants
|
0.04 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 96 to <108
|
—
|
0.057 proportion of participants
|
0.04 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 108 to <120
|
—
|
0.057 proportion of participants
|
0.045 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 120 to <132
|
—
|
0.06 proportion of participants
|
0.047 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 132 to <144
|
—
|
0.06 proportion of participants
|
0.047 proportion of participants
|
—
|
|
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Interval Week 144 to <168
|
—
|
0.062 proportion of participants
|
0.047 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
|
—
|
-2.7 log10 copies/mL
Standard Deviation 0.9
|
-2.8 log10 copies/mL
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: baseline, week 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases
Outcome measures
| Measure |
NVP IR 200mg QD
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=506 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=505 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
|
—
|
239.3 cells/cubic millimeter
Standard Deviation 171.4
|
270.7 cells/cubic millimeter
Standard Deviation 183.1
|
—
|
SECONDARY outcome
Timeframe: until last patient completed 144 weeks (up to 193 weeks)Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Frequency of patients with drug related rash events by functional grouping
Outcome measures
| Measure |
NVP IR 200mg QD
n=191 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=315 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
n=315 Participants
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Occurrence of Rashes
rash group I
|
9 participants
|
11 participants
|
6 participants
|
0 participants
|
|
Occurrence of Rashes
rash group II
|
6 participants
|
13 participants
|
3 participants
|
0 participants
|
|
Occurrence of Rashes
rash group IIA
|
4 participants
|
5 participants
|
1 participants
|
0 participants
|
|
Occurrence of Rashes
rash group III
|
3 participants
|
5 participants
|
0 participants
|
0 participants
|
|
Occurrence of Rashes
rash group IV
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: until last patient completed 144 weeks (up to 193 weeks)Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Outcome measures
| Measure |
NVP IR 200mg QD
n=191 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=315 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
n=315 Participants
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
DAIDS grade 3 or 4 AEs
|
53 participants
|
111 participants
|
71 participants
|
8 participants
|
|
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
DAIDS grade 4 AEs
|
17 participants
|
25 participants
|
11 participants
|
3 participants
|
SECONDARY outcome
Timeframe: week 0 to 144Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Outcome measures
| Measure |
NVP IR 200mg QD
n=506 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 0 to <2
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 2 to <4
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 4 to <6
|
0.034 cumulative probability
|
0.026 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 6 to <8
|
0.067 cumulative probability
|
0.046 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 8 to <12
|
0.081 cumulative probability
|
0.059 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 12 to <16
|
0.093 cumulative probability
|
0.067 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 16 to <24
|
0.113 cumulative probability
|
0.083 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 24 to <32
|
0.130 cumulative probability
|
0.115 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 32 to <40
|
0.156 cumulative probability
|
0.139 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 40 to <48
|
0.172 cumulative probability
|
0.156 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 48 to <60
|
0.192 cumulative probability
|
0.162 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 60 to <72
|
0.202 cumulative probability
|
0.176 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 72 to <84
|
0.213 cumulative probability
|
0.188 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 84 to <96
|
0.229 cumulative probability
|
0.206 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 96 to <108
|
0.243 cumulative probability
|
0.218 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 108 to <120
|
0.267 cumulative probability
|
0.232 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 120 to <132
|
0.275 cumulative probability
|
0.236 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Interval Week 132 to <144
|
0.289 cumulative probability
|
0.244 cumulative probability
|
—
|
—
|
SECONDARY outcome
Timeframe: week 0 to 72Population: Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Outcome measures
| Measure |
NVP IR 200mg QD
n=506 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 0 to <2
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 2 to <4
|
0.000 cumulative probability
|
0.002 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 4 to <6
|
0.012 cumulative probability
|
0.014 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 6 to <8
|
0.049 cumulative probability
|
0.026 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 8 to <12
|
0.059 cumulative probability
|
0.034 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 12 to <16
|
0.063 cumulative probability
|
0.036 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 16 to <24
|
0.063 cumulative probability
|
0.036 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 24 to <32
|
0.067 cumulative probability
|
0.043 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 32 to <40
|
0.070 cumulative probability
|
0.049 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 40 to <48
|
0.076 cumulative probability
|
0.056 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 48 to <60
|
0.076 cumulative probability
|
0.058 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week 60 to <72
|
0.076 cumulative probability
|
0.058 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Interval Week >=72
|
0.076 cumulative probability
|
0.070 cumulative probability
|
—
|
—
|
SECONDARY outcome
Timeframe: week 0 to 72Population: Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Outcome measures
| Measure |
NVP IR 200mg QD
n=506 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 0 to <2
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 2 to <4
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 4 to <6
|
0.006 cumulative probability
|
0.002 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 6 to <8
|
0.027 cumulative probability
|
0.006 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 8 to <12
|
0.033 cumulative probability
|
0.008 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 12 to <16
|
0.039 cumulative probability
|
0.008 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 16 to <24
|
0.039 cumulative probability
|
0.008 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 24 to <32
|
0.042 cumulative probability
|
0.015 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 32 to <40
|
0.044 cumulative probability
|
0.019 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 40 to <48
|
0.053 cumulative probability
|
0.028 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 48 to <60
|
0.053 cumulative probability
|
0.031 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week 60 to <72
|
0.053 cumulative probability
|
0.033 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Interval Week >=72
|
0.053 cumulative probability
|
0.033 cumulative probability
|
—
|
—
|
SECONDARY outcome
Timeframe: week 0 to 72Population: Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Outcome measures
| Measure |
NVP IR 200mg QD
n=506 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 0 to <2
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 2 to <4
|
0.000 cumulative probability
|
0.002 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 4 to <6
|
0.012 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 6 to <8
|
0.022 cumulative probability
|
0.016 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 8 to <12
|
0.024 cumulative probability
|
0.018 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 12 to <16
|
0.026 cumulative probability
|
0.018 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 16 to <24
|
0.026 cumulative probability
|
0.018 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 24 to <32
|
0.026 cumulative probability
|
0.020 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 32 to <40
|
0.026 cumulative probability
|
0.022 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 40 to <48
|
0.029 cumulative probability
|
0.022 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 48 to <60
|
0.029 cumulative probability
|
0.022 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week 60 to <72
|
0.032 cumulative probability
|
0.022 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Interval Week >=72
|
0.038 cumulative probability
|
0.026 cumulative probability
|
—
|
—
|
SECONDARY outcome
Timeframe: week 0 to 72Population: Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose
Outcome measures
| Measure |
NVP IR 200mg QD
n=506 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 48 to <60
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 60 to <72
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 0 to <2
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 2 to <4
|
0.000 cumulative probability
|
0.000 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 4 to <6
|
0.002 cumulative probability
|
0.006 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 6 to <8
|
0.004 cumulative probability
|
0.008 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 8 to <12
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 12 to <16
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 16 to <24
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 24 to <32
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 32 to <40
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week 40 to <48
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
|
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Interval Week >=72
|
0.004 cumulative probability
|
0.010 cumulative probability
|
—
|
—
|
SECONDARY outcome
Timeframe: week 132Population: Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.
Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.
Outcome measures
| Measure |
NVP IR 200mg QD
n=276 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=311 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Relative Bioavailability Trough C_pre,ss,1
|
4567.03 ng/mL
Geometric Coefficient of Variation 49.9
|
3634.26 ng/mL
Geometric Coefficient of Variation 49.9
|
—
|
—
|
SECONDARY outcome
Timeframe: until last patient completed 144 weeks (up to 193 weeks)Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication
Frequency of patients with hepatitis symptoms
Outcome measures
| Measure |
NVP IR 200mg QD
n=191 Participants
Nevirapine immediate release 200 mg tablets given once daily
|
NVP IR 200mg BID
n=505 Participants
Nevirapine immediate release 200 mg tablets given twice daily
|
NVP XR 400mg QD
n=315 Participants
Nevirapine extended release 400 mg tablets given once daily
|
XR-IR/XR
n=315 Participants
Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|
|
Occurrence of Hepatic Events
|
10 participants
|
8 participants
|
2 participants
|
0 participants
|
Adverse Events
NVP IR 200mg QD
Serious events: 20 serious events
Other events: 308 other events
Deaths: 0 deaths
NVP IR
Serious events: 33 serious events
Other events: 131 other events
Deaths: 0 deaths
NVP XR
Serious events: 93 serious events
Other events: 403 other events
Deaths: 0 deaths
NVP IR-IR/XR
Serious events: 50 serious events
Other events: 271 other events
Deaths: 0 deaths
NVP XR-IR/XR
Serious events: 9 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NVP IR 200mg QD
n=1068 participants at risk
Nevirapine immediate release 200 mg given once daily
|
NVP IR
n=191 participants at risk
Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
|
NVP XR
n=505 participants at risk
Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
|
NVP IR-IR/XR
n=315 participants at risk
Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
|
NVP XR-IR/XR
n=315 participants at risk
Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|---|
|
Infections and infestations
AIDS encephalopathy
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Pericardial rub
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Eye disorders
Strabismus
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Oral disorder
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Face oedema
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Gait disturbance
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Hyperplasia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Influenza like illness
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Polyserositis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Pyrexia
|
0.19%
2/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.0%
2/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Immune system disorders
Drug hypersensitivity
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Immune system disorders
Hypersensitivity
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Abscess
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Anal abscess
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Eye infection syphilitic
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Furuncle
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Giardiasis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Groin abscess
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Lung abscess
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis histoplasma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis tuberculous
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Neurocryptococcosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Orchitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.6%
3/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.4%
7/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Rectal abscess
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Sepsis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.59%
3/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Shigella infection
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Syphilis
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.0%
2/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Catheterisation cardiac normal
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.59%
3/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Investigations
Transaminases increased
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.59%
3/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid sarcoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.6%
3/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma localised
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine carcinoma in situ
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Cervical root pain
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Headache
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Syncope
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Aggression
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Depression
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.79%
4/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Social phobia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Epididymitis
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Infertility female
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Drug rash with eosinophilia and systemic symptoms
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.19%
2/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.1%
4/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Social circumstances
Aborted pregnancy
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Social circumstances
Alcohol use
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.40%
2/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Hypertension
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Hypotension
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Secondary hypertension
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.52%
1/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.20%
1/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
Other adverse events
| Measure |
NVP IR 200mg QD
n=1068 participants at risk
Nevirapine immediate release 200 mg given once daily
|
NVP IR
n=191 participants at risk
Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
|
NVP XR
n=505 participants at risk
Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
|
NVP IR-IR/XR
n=315 participants at risk
Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
|
NVP XR-IR/XR
n=315 participants at risk
Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
8/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.7%
7/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.0%
25/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.9%
25/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
27/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
14.1%
27/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
18.6%
94/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
20.0%
63/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.2%
7/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Nausea
|
6.6%
71/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
9.4%
18/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.5%
38/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
12.1%
38/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
16/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.8%
11/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.9%
35/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.0%
22/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Fatigue
|
3.7%
40/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.2%
10/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.7%
34/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
8.9%
28/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
General disorders
Pyrexia
|
1.9%
20/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.3%
12/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.0%
25/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.8%
12/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Bronchitis
|
0.66%
7/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.3%
12/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
14.1%
71/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
11.1%
35/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.3%
4/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Gastroenteritis
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.2%
10/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.1%
36/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
8.6%
27/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Herpes zoster
|
0.56%
6/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.7%
7/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.1%
26/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.4%
17/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Influenza
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.7%
9/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.5%
33/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.9%
25/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Nasopharyngitis
|
0.94%
10/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
8.9%
17/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
24.4%
123/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
27.6%
87/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.8%
15/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Pharyngitis
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.7%
7/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.5%
33/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.3%
23/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Sinusitis
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.6%
5/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.3%
37/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.0%
22/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Syphilis
|
0.09%
1/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.2%
8/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.5%
28/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.0%
19/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.2%
7/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
13/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
12.0%
23/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
16.4%
83/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
15.9%
50/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.8%
12/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Infections and infestations
Urinary tract infection
|
0.19%
2/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.1%
4/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.1%
26/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.8%
12/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.6%
5/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
4/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.7%
9/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.5%
33/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.9%
25/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.9%
9/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
7/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.6%
5/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.9%
40/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
9.5%
30/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.5%
8/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.37%
4/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.6%
5/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.2%
16/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.3%
20/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.37%
4/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.6%
3/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.7%
29/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.1%
16/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.00%
0/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.28%
3/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
2.1%
4/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.8%
19/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.1%
16/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Nervous system disorders
Headache
|
5.4%
58/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
9.4%
18/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
12.1%
61/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
17.5%
55/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Anxiety
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.7%
7/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.0%
20/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.1%
16/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Depression
|
0.75%
8/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
3.7%
7/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.3%
37/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
9.8%
31/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.9%
6/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Psychiatric disorders
Insomnia
|
0.75%
8/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.7%
9/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.3%
27/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.0%
19/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.32%
1/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
11/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.3%
14/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
10.3%
52/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
11.4%
36/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.56%
6/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
1.6%
3/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
5.9%
30/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
4.1%
13/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
74/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
13.6%
26/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
11.1%
56/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.9%
25/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.63%
2/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
|
Vascular disorders
Hypertension
|
0.47%
5/1068 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
6.8%
13/191 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.5%
38/505 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
7.0%
22/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
0.95%
3/315 • Up to 193 weeks
Safety data in this report included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial. This also includes safety data for patient visits in the post week 144 open label extension which patients in either treatment group who completed the 144 week blinded phase could enter (see also Limitation).
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER