Trial Outcomes & Findings for Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (NCT NCT00451451)
NCT ID: NCT00451451
Last Updated: 2015-01-26
Results Overview
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1417 participants
Primary outcome timeframe
2 years
Results posted on
2015-01-26
Participant Flow
Subjects were randomized at 205 investigational sites in 28 countries.
From screening, 1430 eligible subjects were equally randomized. Of these, 1417 subjects received at least one dose of study treatment and comprised the intent-to-treat (ITT) and safety populations.
Participant milestones
| Measure |
Placebo
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
363
|
359
|
345
|
350
|
|
Overall Study
COMPLETED
|
278
|
284
|
273
|
292
|
|
Overall Study
NOT COMPLETED
|
85
|
75
|
72
|
58
|
Reasons for withdrawal
| Measure |
Placebo
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
21
|
26
|
10
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
8
|
11
|
|
Overall Study
Consent Withdrawn
|
14
|
9
|
17
|
17
|
|
Overall Study
Investigator Decision
|
6
|
2
|
1
|
2
|
|
Overall Study
Subject Non-Compliance
|
8
|
4
|
3
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
|
Overall Study
Other Reasons for Not Completing Study
|
34
|
30
|
17
|
14
|
Baseline Characteristics
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=363 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=345 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=350 Participants
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
Total
n=1417 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.9 Years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
37.8 Years
STANDARD_DEVIATION 9.35 • n=7 Participants
|
37.8 Years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
36.7 Years
STANDARD_DEVIATION 9.06 • n=4 Participants
|
37.3 Years
STANDARD_DEVIATION 9.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
993 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
424 Participants
n=21 Participants
|
|
Mean Expanded Disability Status Scale (EDSS) score
|
2.59 units on a scale
STANDARD_DEVIATION 1.170 • n=5 Participants
|
2.56 units on a scale
STANDARD_DEVIATION 1.202 • n=7 Participants
|
2.52 units on a scale
STANDARD_DEVIATION 1.185 • n=5 Participants
|
2.57 units on a scale
STANDARD_DEVIATION 1.223 • n=4 Participants
|
2.56 units on a scale
STANDARD_DEVIATION 1.194 • n=21 Participants
|
|
Mean number of relapses within the previous 3 years
|
2.5 Number of relapses
STANDARD_DEVIATION 1.46 • n=5 Participants
|
2.4 Number of relapses
STANDARD_DEVIATION 1.27 • n=7 Participants
|
2.6 Number of relapses
STANDARD_DEVIATION 1.50 • n=5 Participants
|
2.4 Number of relapses
STANDARD_DEVIATION 1.32 • n=4 Participants
|
2.5 Number of relapses
STANDARD_DEVIATION 1.39 • n=21 Participants
|
|
Mean number of relapses within the past 12 months
|
1.4 Number of relapses
STANDARD_DEVIATION 0.80 • n=5 Participants
|
1.3 Number of relapses
STANDARD_DEVIATION 0.63 • n=7 Participants
|
1.4 Number of relapses
STANDARD_DEVIATION 0.72 • n=5 Participants
|
1.4 Number of relapses
STANDARD_DEVIATION 0.64 • n=4 Participants
|
1.4 Number of relapses
STANDARD_DEVIATION 0.70 • n=21 Participants
|
|
Time since first multiple sclerosis (MS) diagnosis
|
4.8 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
4.9 years
STANDARD_DEVIATION 5.11 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 5.23 • n=5 Participants
|
4.4 years
STANDARD_DEVIATION 4.70 • n=4 Participants
|
4.7 years
STANDARD_DEVIATION 5.01 • n=21 Participants
|
|
Mean number of Gadolinium(Gd)-enhancing T1-weighted lesions
|
2.7 Number of Gd enhancing lesions
STANDARD_DEVIATION 7.71 • n=5 Participants
|
2.7 Number of Gd enhancing lesions
STANDARD_DEVIATION 6.22 • n=7 Participants
|
1.9 Number of Gd enhancing lesions
STANDARD_DEVIATION 5.02 • n=5 Participants
|
2.4 Number of Gd enhancing lesions
STANDARD_DEVIATION 6.81 • n=4 Participants
|
2.4 Number of Gd enhancing lesions
STANDARD_DEVIATION 6.51 • n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\>2.0), age (\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.
Outcome measures
| Measure |
Placebo
n=363 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=345 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=350 Participants
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Annualized Relapse Rate
|
0.401 Relapses Per Year
Interval 0.329 to 0.488
|
0.224 Relapses Per Year
Interval 0.179 to 0.282
|
0.198 Relapses Per Year
Interval 0.156 to 0.252
|
0.286 Relapses Per Year
Interval 0.232 to 0.353
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.
The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.
Outcome measures
| Measure |
Placebo
n=139 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=140 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=140 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=153 Participants
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Number of New or Newly Enlarging T2 Hyperintense Lesions
|
17.4 Number of lesions
Interval 13.5 to 22.4
|
5.1 Number of lesions
Interval 3.9 to 6.6
|
4.7 Number of lesions
Interval 3.6 to 6.2
|
8.0 Number of lesions
Interval 6.3 to 10.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data \& were included in the analysis. Missing data before the use of alternative MS medications \& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption
The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.
Outcome measures
| Measure |
Placebo
n=139 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=140 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=140 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=153 Participants
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Number of New T1 Hypointense Lesions
|
7.0 Number of lesions
Interval 5.3 to 9.2
|
3.0 Number of lesions
Interval 2.3 to 4.0
|
2.4 Number of lesions
Interval 1.8 to 3.2
|
4.1 Number of lesions
Interval 3.2 to 5.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.
Outcome measures
| Measure |
Placebo
n=363 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=345 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=350 Participants
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Proportion of Subjects Relapsed
|
0.410 Proportion of subjects,confirmed relapse
|
0.291 Proportion of subjects,confirmed relapse
|
0.241 Proportion of subjects,confirmed relapse
|
0.321 Proportion of subjects,confirmed relapse
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.
EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution
Outcome measures
| Measure |
Placebo
n=363 Participants
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 Participants
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=345 Participants
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=350 Participants
Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|
|
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
|
0.169 Proportion of Participants
|
0.128 Proportion of Participants
|
0.130 Proportion of Participants
|
0.156 Proportion of Participants
|
Adverse Events
Placebo
Serious events: 79 serious events
Other events: 332 other events
Deaths: 0 deaths
BG00012 240 mg Twice Daily (BID)
Serious events: 61 serious events
Other events: 336 other events
Deaths: 0 deaths
BG00012 240 mg 3 Times Daily (TID)
Serious events: 54 serious events
Other events: 316 other events
Deaths: 0 deaths
Total BG00012
Serious events: 115 serious events
Other events: 652 other events
Deaths: 0 deaths
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
Serious events: 60 serious events
Other events: 303 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=363 participants at risk
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 participants at risk
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=344 participants at risk
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Total BG00012
n=703 participants at risk
Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=351 participants at risk
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.56%
2/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.58%
2/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.57%
4/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.56%
2/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.43%
3/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
DOUGLAS' ABSCESS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
BORRELIA INFECTION
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
INFLUENZA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
PNEUMONIA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.57%
2/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
PYOTHORAX
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
SEPSIS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
TRACHEITIS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST NEOPLASM
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FIBROMA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER METASTATIC
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.57%
2/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.57%
2/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
ANXIETY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
14.0%
51/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.9%
39/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.7%
30/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.8%
69/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.3%
36/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
BENIGN INTRACRANIAL HYPERTENSION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
MIGRAINE
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
OCCIPITAL NEURALGIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
CONVULSION
|
0.55%
2/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
EPILEPSY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Eye disorders
EYE PAIN
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Eye disorders
HOLMES-ADIE PUPIL
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Ear and labyrinth disorders
VESTIBULAR ATAXIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.56%
2/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
VOMITING
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
DUODENITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
NAUSEA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.56%
2/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
BLADDER DYSFUNCTION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
BLADDER PERFORATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
BLADDER DIVERTICULUM
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
NEPHROPTOSIS
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.55%
2/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL OEDEMA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Reproductive system and breast disorders
BARTHOLIN'S CYST
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
ASTHENIA
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
PYREXIA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Investigations
BETA 2 MICROGLOBULIN URINE INCREASED
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.58%
2/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
2/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT TOXICITY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Injury, poisoning and procedural complications
WHIPLASH INJURY
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
BREAST LUMP REMOVAL
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
INTERVERTEBRAL DISC OPERATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.29%
1/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
MEDICAL DIET
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.14%
1/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
CERVICAL CONISATION
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
STERILISATION
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.28%
1/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Surgical and medical procedures
TURBINECTOMY
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Social circumstances
SOCIAL PROBLEM
|
0.28%
1/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
Other adverse events
| Measure |
Placebo
n=363 participants at risk
Participants received two placebo capsules orally three times daily (TID)
|
BG00012 240 mg Twice Daily (BID)
n=359 participants at risk
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
|
BG00012 240 mg 3 Times Daily (TID)
n=344 participants at risk
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
|
Total BG00012
n=703 participants at risk
Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
|
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)
n=351 participants at risk
Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.9%
14/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.6%
13/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.1%
21/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.8%
34/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.3%
8/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.0%
29/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.8%
21/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.6%
26/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.7%
47/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.0%
21/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
PROTEINURIA
|
6.9%
25/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.1%
29/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.2%
35/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.1%
64/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.5%
30/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.1%
15/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.0%
25/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.6%
26/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.3%
51/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.1%
4/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
VOMITING
|
3.3%
12/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.0%
25/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.7%
23/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.8%
48/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.3%
8/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.2%
8/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.3%
12/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.7%
16/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.0%
28/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.7%
6/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.6%
13/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.7%
24/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.1%
28/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.4%
52/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.3%
8/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Skin and subcutaneous tissue disorders
PRURITIS
|
3.0%
11/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.6%
20/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.0%
24/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.3%
44/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.0%
7/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.4%
5/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.5%
16/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.1%
21/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.3%
37/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.7%
6/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.1%
33/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.5%
34/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.5%
36/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.0%
70/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.1%
32/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.2%
26/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.6%
20/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.8%
27/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.7%
47/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.8%
17/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.0%
58/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
17.3%
62/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
18.3%
63/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
17.8%
125/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
14.5%
51/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.6%
42/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
14.2%
51/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
11.6%
40/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
12.9%
91/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.1%
46/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
34/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.0%
36/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.7%
47/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
11.8%
83/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.7%
27/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
INFLUENZA
|
6.1%
22/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.6%
20/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.3%
25/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.4%
45/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
BRONCHITIS
|
3.9%
14/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.9%
14/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.4%
22/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.1%
36/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.6%
16/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Infections and infestations
SINUSITIS
|
3.0%
11/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.0%
18/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.2%
18/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.1%
36/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.1%
11/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
DEPRESSION
|
9.6%
35/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.7%
24/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.4%
15/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.5%
39/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.0%
28/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Psychiatric disorders
INSOMNIA
|
5.0%
18/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.2%
15/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.9%
10/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.6%
25/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.7%
13/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
40.5%
147/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
29.0%
104/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
23.5%
81/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
26.3%
185/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
32.8%
115/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
HEADACHE
|
13.5%
49/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
14.5%
52/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.4%
46/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.9%
98/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.1%
46/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
PARAESTHESIA
|
8.5%
31/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.8%
21/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.1%
21/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.0%
42/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.8%
21/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.1%
11/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.5%
19/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
30/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.6%
16/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Ear and labyrinth disorders
VERTIGO
|
6.1%
22/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.5%
9/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.8%
13/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.1%
22/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Vascular disorders
FLUSHING
|
3.6%
13/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
30.6%
110/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
24.1%
83/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
27.5%
193/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.7%
6/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Vascular disorders
HOT FLUSH
|
2.2%
8/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.0%
18/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.5%
19/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.3%
37/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.1%
4/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.7%
17/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.5%
16/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.2%
18/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.8%
34/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.6%
9/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.9%
14/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.3%
12/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.1%
21/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.7%
33/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
DIARRHEA
|
7.7%
28/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
12.5%
45/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
14.5%
50/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
13.5%
95/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.0%
14/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
NAUSEA
|
8.0%
29/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
11.1%
40/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
14.8%
51/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
12.9%
91/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.7%
17/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.0%
36/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.6%
33/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.8%
69/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
1.1%
4/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Renal and urinary disorders
MICROALBUMINURIA
|
3.6%
13/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.9%
14/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.5%
19/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.7%
33/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
FATIGUE
|
9.1%
33/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.3%
37/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
9.6%
33/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
10.0%
70/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.5%
30/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
PYREXIA
|
5.2%
19/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.1%
11/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
7.0%
24/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.0%
35/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.8%
17/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.8%
31/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
0.00%
0/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
8.3%
29/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.9%
25/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.5%
16/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.4%
22/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.4%
38/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.7%
20/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Investigations
ALBUMIN URINE PRESENT
|
4.1%
15/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
6.1%
22/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.1%
14/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.1%
36/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.1%
18/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
|
Investigations
PROTEIN URINE PRESENT
|
2.8%
10/363 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
5.0%
18/359 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
2.0%
7/344 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
3.6%
25/703 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
4.3%
15/351 • 2 years
The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The provisions of our agreement are subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication
- Publication restrictions are in place
Restriction type: OTHER