Trial Outcomes & Findings for A Trial of PF-06252616 in Ambulatory Participants With LGMD2I (NCT NCT02841267)
NCT ID: NCT02841267
Last Updated: 2020-10-19
Results Overview
Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline through 64 weeks
Results posted on
2020-10-19
Participant Flow
One participant in Cohort 2 was consented, but elected to withdraw from the study prior to assignment to a treatment arm.
Participant milestones
| Measure |
Low Dose, Cohort 1
4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
PF 06252616
|
Middle Dose, Cohort 2
8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
PF 06252616
|
High Dose, Cohort 3
8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
PF 06252616
|
|---|---|---|---|
|
Lead-in (Untreated)
STARTED
|
4
|
7
|
8
|
|
Lead-in (Untreated)
COMPLETED
|
4
|
7
|
8
|
|
Lead-in (Untreated)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
4
|
7
|
8
|
|
Treatment Period
COMPLETED
|
4
|
7
|
8
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Extension Study
STARTED
|
4
|
6
|
6
|
|
Extension Study
COMPLETED
|
4
|
6
|
6
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
Baseline characteristics by cohort
| Measure |
Cohort 1 - Low Dose
n=4 Participants
4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2 - Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3 - High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 8 • n=5 Participants
|
41 years
STANDARD_DEVIATION 18 • n=7 Participants
|
34 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
39 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through 64 weeksPopulation: All enrolled subjects are included in the analysis.
Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale).
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events
Any adverse event
|
45 events
|
21 events
|
40 events
|
|
Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events
Serious adverse event
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3Population: All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period.
The concentration of myostatin (GDF-8) was measured in serum 2 hours after dose administration at two visits (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3)where drug concentration had reached steady state. The highest concentration from these two time points was averaged for each cohort.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration at Steady State (Cmax, ss) of GDF-8
|
9.02 ng/ml
Standard Deviation 3.20
|
8.96 ng/ml
Standard Deviation 3.02
|
9.67 ng/ml
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3Population: All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period.
The concentration of myostatin (GDF-8) was measured in serum prior to dose administration at two time points (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3) where drug concentration had reached steady state. The lowest concentration from these two time points was averaged for each cohort.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) of GDF-8
|
8.80 ng/ml
Standard Deviation 2.96
|
9.68 ng/ml
Standard Deviation 2.21
|
9.78 ng/ml
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Day 113 and Day 169Population: All enrolled participants were analyzed. For Cohort 1, measurements are provided for 5mg/kg dosing period.
The peak concentration of study drug (PF-06252616) was measured in serum following dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The higher concentration from these two time points was averaged for each cohort.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of PF-06252616
|
215306.5 ng/ml
Standard Deviation 29490.4
|
779015.7 ng/ml
Standard Deviation 115450.0
|
1625203 ng/ml
Standard Deviation 271159.6
|
SECONDARY outcome
Timeframe: Day 113 and Day 169Population: All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period.
The peak concentration of study drug (PF-06252616) was measured in serum prior to dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The lower concentration from these two time points was averaged for each cohort.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=7 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Minimum Observed Serum Trough Concentration (Ctrough) of PF-06252616
|
67016.8 ng/ml
Standard Deviation 25887.3
|
224024.1 ng/ml
Standard Deviation 58734.5
|
408814.1 ng/ml
Standard Deviation 96607.6
|
SECONDARY outcome
Timeframe: Baseline through 96 weeksPopulation: All enrolled subjects were included in the analysis.
Blood samples were tested for the presence of anti-drug antibodies prior to the initiation of study drug, at dose escalation (Cohort 1 only), and at 3 separate time points after the last dose was given.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Immunogenicity: Incidence of Anti-drug Antibody
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: All enrolled subject were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.
Subjects are asked to run or walk as quickly as possible for 10 meters from a standing position. The total time to traverse 10 meters is recorded in seconds.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in 10 Meter Walk/Run Time in Seconds
|
1.60 seconds
Standard Deviation 2.95
|
-0.09 seconds
Standard Deviation 0.11
|
0.18 seconds
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: All enrolled subjects were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.
The total forced vital capacity was measured using a bedside spirometer. The best of 3 trials was recorded.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline of Forced Vital Capacity in Liters
|
0.03 liters
Standard Deviation 0.14
|
0.02 liters
Standard Deviation 0.15
|
-0.05 liters
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period.
Average change in distance (in meters) walked in 2 minutes.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in 2MWD in Meters
|
-4.25 meters
Standard Deviation 9.91
|
2.00 meters
Standard Deviation 7.77
|
2.13 meters
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: All enrolled subjects are included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.
The timed-up-and-go test (TUG) is the total time it takes the subject to rise from a seated position, walk to a marker 3 meters away, return to the chair, and sit.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in TUG in Seconds
|
0.67 seconds
Standard Deviation 1.15
|
0.29 seconds
Standard Deviation 1.11
|
-0.50 seconds
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: All enrolled participants were analyzed after 32 weeks of treatment.
Twenty-two muscle groups were measured on a modified MRC scale ranging from 1 through 12. The total scores from all 22 muscle groups were added to generate a summary score ranging from 12 to 264 with higher scores signifying greater strength. The change in summary score was calculated over the first 32 weeks of treatment.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 2, Middle Dose
n=7 Participants
7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3, High Dose
n=8 Participants
8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.
|
|---|---|---|---|
|
Mean Change From Baseline in Muscle Strength as Measured by Modified MRC Scale
|
9.75 score on a scale
Standard Deviation 6.18
|
7.57 score on a scale
Standard Deviation 8.62
|
2.43 score on a scale
Standard Deviation 4.54
|
Adverse Events
Lead-in
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 1 - Low Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 - High Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 Extension
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 Extension
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3 Extension
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-in
n=19 participants at risk
All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts.
|
Cohort 1 - Low Dose
n=4 participants at risk
Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 1 - High Dose
n=4 participants at risk
Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 1 Extension
n=4 participants at risk
Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks.
|
Cohort 2
n=7 participants at risk
Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 2 Extension
n=6 participants at risk
Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks.
|
Cohort 3
n=8 participants at risk
Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3 Extension
n=6 participants at risk
Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Stress fracture
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
Other adverse events
| Measure |
Lead-in
n=19 participants at risk
All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts.
|
Cohort 1 - Low Dose
n=4 participants at risk
Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 1 - High Dose
n=4 participants at risk
Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.
|
Cohort 1 Extension
n=4 participants at risk
Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks.
|
Cohort 2
n=7 participants at risk
Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 2 Extension
n=6 participants at risk
Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks.
|
Cohort 3
n=8 participants at risk
Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.
|
Cohort 3 Extension
n=6 participants at risk
Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Elevated serum iron levels
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
2/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
33.3%
2/6 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Pain associated with muscle biopsy
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Numbness following biopsy
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Lower extremity edema following biopsy
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Skin avulsion following biopsy
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Intravenous catheter infiltration
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Ecchymosis at IV site
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Fall - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Musculoskeletal pain post fall
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
2/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
33.3%
2/6 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
3/6 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Fracture - pelvic
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Knee injury post fall
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
2/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Shoulder injury post fall
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
2/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Facial injury post fall
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Ankle injury post fall
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
2/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain - not otherwise specified
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Knee pain - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Musculoskeletal and connective tissue disorders
Hip pain - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Cardiac disorders
Worsening cardiomyopathy
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
42.9%
3/7 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
2/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Upper respiratory symptoms
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
50.0%
2/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
75.0%
3/4 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
42.9%
3/7 • Number of events 3 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
2/8 • Number of events 5 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Flu-like illness
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Immune system disorders
Environmental allergies
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Infectious illness - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
2/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
General disorders
Decreased appetite
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Renal and urinary disorders
Urinary tract infection
|
10.5%
2/19 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Renal and urinary disorders
Prostatic hypertrophy
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Reproductive system and breast disorders
Vaginal yeast infection
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Eye disorders
Blepharitis
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Eye disorders
Vision abnormality - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Eye disorders
Eye twitching
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Rash - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Cold sore
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Cyst - not otherwise specified
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Injury, poisoning and procedural complications
Dental injury
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Infections and infestations
Dental infection
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
2/8 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
General disorders
Syncope
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
General disorders
Hypoglycemia
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Ketones detected in urine
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Red blood cells in urine
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Low serum iron levels
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
28.6%
2/7 • Number of events 2 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
16.7%
1/6 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Elevated amylase
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Elevated serum ferritin
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Investigations
Low serum ferritin
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
14.3%
1/7 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
Hemoccult positive
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Nervous system disorders
New diagnosis - carpal tunnel syndrome
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
25.0%
1/4 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/8 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Hepatobiliary disorders
New diagnosis - hepatic steatosis
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Gastrointestinal disorders
New diagnosis - umbilical hernia
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Psychiatric disorders
New diagnosis - bipolar disorder
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
|
Psychiatric disorders
New diagnosis - personality disorder
|
0.00%
0/19 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/4 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/7 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
12.5%
1/8 • Number of events 1 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
0.00%
0/6 • Baseline through 124 weeks
Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.
|
Additional Information
Dr. Kathryn R. Wagner
Hugo W. Moser Research Institute at Kennedy Krieger Inc.
Phone: 443-923-9525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place