Trial Outcomes & Findings for Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) (NCT NCT01360866)
NCT ID: NCT01360866
Last Updated: 2018-09-17
Results Overview
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2944 participants
Primary outcome timeframe
From screening to week 52/early termination
Results posted on
2018-09-17
Participant Flow
This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).
The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.
Participant milestones
| Measure |
Prior Placebo
Participants who received placebo with antidepressant therapy \[ADT\] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
516
|
707
|
1645
|
76
|
|
Overall Study
COMPLETED
|
295
|
420
|
1126
|
54
|
|
Overall Study
NOT COMPLETED
|
221
|
287
|
519
|
22
|
Reasons for withdrawal
| Measure |
Prior Placebo
Participants who received placebo with antidepressant therapy \[ADT\] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
28
|
41
|
0
|
|
Overall Study
Adverse Event
|
56
|
61
|
134
|
6
|
|
Overall Study
Paticipant met withdrawal criteria
|
11
|
28
|
54
|
0
|
|
Overall Study
Withdrawn by Investigator
|
9
|
8
|
31
|
2
|
|
Overall Study
Withdrawal by participant
|
79
|
89
|
168
|
8
|
|
Overall Study
Protocol Deviation
|
25
|
33
|
61
|
2
|
|
Overall Study
Lack of Efficacy
|
30
|
40
|
30
|
4
|
Baseline Characteristics
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Baseline characteristics by cohort
| Measure |
Prior Placebo
n=516 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=707 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1645 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=76 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Total
n=2944 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
45.0 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
367 Participants
n=5 Participants
|
479 Participants
n=7 Participants
|
1108 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
2005 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
537 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
939 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
452 Participants
n=5 Participants
|
609 Participants
n=7 Participants
|
1459 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
2588 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
55 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
288 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From screening to week 52/early terminationPopulation: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
Outcome measures
| Measure |
Prior Placebo
n=516 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=706 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1640 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=76 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Adverse Events (AEs) - All Participants
Participants with adverse events
|
400 Participants
|
511 Participants
|
1165 Participants
|
51 Participants
|
|
Adverse Events (AEs) - All Participants
Participants with treatment emergent AE (TEAE)
|
399 Participants
|
510 Participants
|
1163 Participants
|
51 Participants
|
|
Adverse Events (AEs) - All Participants
Participants with serious TEAE
|
14 Participants
|
23 Participants
|
33 Participants
|
1 Participants
|
|
Adverse Events (AEs) - All Participants
Participants with severe TEAE
|
48 Participants
|
64 Participants
|
99 Participants
|
4 Participants
|
|
Adverse Events (AEs) - All Participants
Partcipants discontinued due to AEs
|
55 Participants
|
58 Participants
|
134 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From screening to week 52/early terminationPopulation: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Outcome measures
| Measure |
Prior Placebo
n=512 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=698 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1630 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=76 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
|
-0.77 units on a scale
Standard Deviation 1.11
|
-0.63 units on a scale
Standard Deviation 1.16
|
-0.48 units on a scale
Standard Deviation 1.04
|
-0.93 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: From screening to week 52/early terminationPopulation: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
Outcome measures
| Measure |
Prior Placebo
n=505 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=693 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1606 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=75 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
|
2.60 units on a scale
Standard Deviation 1.30
|
2.63 units on a scale
Standard Deviation 1.34
|
2.63 units on a scale
Standard Deviation 1.39
|
2.40 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: From screening to week 52/early terminationPopulation: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.
Outcome measures
| Measure |
Prior Placebo
n=346 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=457 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1165 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=53 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
|
-0.80 units on a scale
Standard Deviation 2.80
|
-0.70 units on a scale
Standard Deviation 2.60
|
-0.40 units on a scale
Standard Deviation 2.30
|
-1.00 units on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: From screening to week 52/early terminationPopulation: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.
Outcome measures
| Measure |
Prior Placebo
n=491 Participants
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=664 Participants
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1556 Participants
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=75 Participants
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
|
-5.25 units on a scale
Standard Deviation 12.21
|
-4.76 units on a scale
Standard Deviation 11.79
|
-3.94 units on a scale
Standard Deviation 10.57
|
-7.44 units on a scale
Standard Deviation 8.89
|
Adverse Events
Prior Placebo
Serious events: 14 serious events
Other events: 296 other events
Deaths: 2 deaths
Prior Brexpiprazole
Serious events: 23 serious events
Other events: 323 other events
Deaths: 2 deaths
Prior ADT
Serious events: 33 serious events
Other events: 787 other events
Deaths: 0 deaths
Prior Seroquel
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prior Placebo
n=516 participants at risk
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=706 participants at risk
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1640 participants at risk
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=76 participants at risk
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Cardiac disorders
Ventricular Dysfunction
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Eye disorders
Blepharospasm
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Eye disorders
Retinal Vein Thrombosis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
General disorders
Chest Pain
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.12%
2/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.12%
2/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Bronchitis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Cellulitis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Peritonitis
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Pneumonia
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
1.3%
1/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
1.3%
1/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neuroendocrine Tumour
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Dizziness
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.12%
2/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Ruptured Cerebral Aneurysm
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Sciatica
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Syncope
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.28%
2/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Depression
|
0.39%
2/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.42%
3/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.18%
3/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Major Depression
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Mania
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Suicide Attempt
|
0.39%
2/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Renal and urinary disorders
Renal Disorder
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Reproductive system and breast disorders
Pelvic Adhesions
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary
|
0.00%
0/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.06%
1/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.39%
2/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.14%
1/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
Other adverse events
| Measure |
Prior Placebo
n=516 participants at risk
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Brexpiprazole
n=706 participants at risk
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior ADT
n=1640 participants at risk
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
Prior Seroquel
n=76 participants at risk
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.7%
14/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
2.1%
15/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
2.0%
33/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.3%
4/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Gastrointestinal disorders
Nausea
|
5.0%
26/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
4.5%
32/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
3.7%
61/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.3%
4/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
General disorders
Fatigue
|
7.2%
37/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
7.1%
50/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.4%
88/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
3.9%
3/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
4.8%
25/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.0%
35/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.0%
98/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
2.6%
2/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Investigations
Weight Increased
|
22.9%
118/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
14.2%
100/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
18.0%
296/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.6%
5/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Metabolism and nutrition disorders
Increased Appetite
|
7.2%
37/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
4.0%
28/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
7.1%
117/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
3.9%
3/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Akathisia
|
10.5%
54/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.2%
37/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.0%
99/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
9.2%
7/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Headache
|
8.1%
42/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
7.8%
55/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.4%
105/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
11.8%
9/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Nervous system disorders
Somnolence
|
7.8%
40/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
8.5%
60/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
7.9%
130/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.6%
5/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Anxiety
|
7.6%
39/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.2%
37/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
4.6%
76/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
0.00%
0/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
|
Psychiatric disorders
Insomnia
|
5.8%
30/516 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
5.7%
40/706 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
6.6%
108/1640 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
7.9%
6/76 • From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 609 524 6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Until the information herein is released by Otsuka to the public domain, the contents of this document are Otsuka confidential information and should not be duplicated or re-distributed without prior written consent of Otsuka.
- Publication restrictions are in place
Restriction type: OTHER