Trial Outcomes & Findings for A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002) (NCT NCT01390441)
NCT ID: NCT01390441
Last Updated: 2016-07-20
Results Overview
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85
Results posted on
2016-07-20
Participant Flow
The study enrolled participants 18 to 65 years of age with a diagnosis of moderate/severe rheumatoid arthritis (RA), naive to treatment or having failed \>=1 anti-TNF agent, and on a stable dose of methotrexate. Not all participants completing the Treatment Period entered the Extension Period due to study early termination.
For Part B only, positive for rheumatoid factor (RF) or, if negative for RF, positive for anti-cyclic citrullinated protein antibodies at the screening visit.
Participant milestones
| Measure |
Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg
Participants receive one course of MK-8808 (500 mg/m\^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
23
|
22
|
18
|
19
|
18
|
|
Treatment Period
COMPLETED
|
22
|
21
|
8
|
6
|
7
|
|
Treatment Period
NOT COMPLETED
|
1
|
1
|
10
|
13
|
11
|
|
Extension Period
STARTED
|
15
|
13
|
1
|
1
|
3
|
|
Extension Period
COMPLETED
|
12
|
12
|
1
|
0
|
3
|
|
Extension Period
NOT COMPLETED
|
3
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg
Participants receive one course of MK-8808 (500 mg/m\^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|
|
Treatment Period
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Unknown due to early stopping of study
|
0
|
0
|
8
|
11
|
7
|
|
Treatment Period
Adverse Event
|
0
|
0
|
1
|
1
|
2
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Extension Period
Protocol Violation
|
3
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)
Baseline characteristics by cohort
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=22 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MK-8808 1000 mg
n=18 Participants
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera® 1000 mg
n=19 Participants
Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
n=18 Participants
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
49.1 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85Population: Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m\^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=22 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=19 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
|
110.56 hr*mg/mL
Interval 94.51 to 129.32
|
110.12 hr*mg/mL
Interval 91.97 to 131.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85Population: PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.
AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeksPopulation: All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=22 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
n=18 Participants
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
n=19 Participants
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
n=18 Participants
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
n=15 Participants
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
n=13 Participants
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
n=1 Participants
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
n=1 Participants
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
n=3 Participants
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
18 Participants
|
21 Participants
|
12 Participants
|
16 Participants
|
13 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeksPopulation: APaT population defined as all participants who received at least one dose of study drug.
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=22 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
n=18 Participants
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
n=19 Participants
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
n=18 Participants
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
n=15 Participants
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
n=13 Participants
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
n=1 Participants
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
n=1 Participants
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
n=3 Participants
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to Adverse Events
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 54, Week 68, Week 80, Week 94, Week 106Population: The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.
Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 54, Week 56, Week 68, Week 80, Week 82, Week 94, Week 106Population: The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.
Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m\^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=22 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=19 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment
|
326.49 ng/mL
Interval 287.72 to 370.49
|
332.39 ng/mL
Interval 287.48 to 384.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.
Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD \& IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=21 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR20
|
23 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR50
|
16 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR70
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD \& IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-"no pain"; right hand marker-"extreme pain" HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=17 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=18 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
n=17 Participants
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR20
|
16 Participants
|
17 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR50
|
12 Participants
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
ACR70
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, Week 12Population: FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.
The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (\<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.
Outcome measures
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 Participants
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera® 500 mg/m^2
n=21 Participants
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan® 1000 mg
Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg
Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera 1000 mg /MK-8808 1000 mg
Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan1000 mg/MK-8808 1000 mg
Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
Week 6 (n=22, n=20)
|
-1.39 Score
Standard Deviation 1.02
|
-1.16 Score
Standard Deviation 1.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
Week 12 (n=21, n=21)
|
-1.68 Score
Standard Deviation 1.12
|
-2.04 Score
Standard Deviation 1.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: MK-8808 500 mg/m^2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Part A: MabThera 500 mg/m^2
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part B: MK-8808 1000 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B: MabThera 1000 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part B: Rituxan 1000 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 participants at risk
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera 500 mg/m^2
n=22 participants at risk
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MK-8808 1000 mg
n=18 participants at risk
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
n=19 participants at risk
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
n=18 participants at risk
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
n=15 participants at risk
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg
n=13 participants at risk
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
n=1 participants at risk
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
n=1 participants at risk
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
n=3 participants at risk
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
Other adverse events
| Measure |
Part A: MK-8808 500 mg/m^2
n=23 participants at risk
Participants receive one course of MK-8808 (500 mg/m\^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part A: MabThera 500 mg/m^2
n=22 participants at risk
Participants receive one course of MabThera® (500 mg/m\^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MK-8808 1000 mg
n=18 participants at risk
Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: MabThera 1000 mg
n=19 participants at risk
Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Part B: Rituxan 1000 mg
n=18 participants at risk
Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg
n=15 participants at risk
Participants who completed Part A MK-8808 500 mg/m\^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg
n=13 participants at risk
Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MK-8808 1000 mg /MK-8808 1000 mg
n=1 participants at risk
Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: MabThera® 1000 mg /MK-8808 1000 mg
n=1 participants at risk
Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg
n=3 participants at risk
Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Hepatitis C
|
13.0%
3/23 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Anisocytosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Polychromasia
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
7.7%
1/13 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Eye disorders
Vision blurred
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
2/23 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
General disorders
Asthenia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
General disorders
Infusion site erythema
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
10.5%
2/19 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
11.1%
2/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
13.6%
3/22 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
11.1%
2/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
6.7%
1/15 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Laryngitis
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
11.1%
2/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
11.1%
2/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
2/23 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
10.5%
2/19 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 5 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Infections and infestations
Viral infection
|
8.7%
2/23 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.0%
3/23 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Blood pressure decreased
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Hepatitis B surface antigen positive
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Red blood cell elliptocytes present
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Renal and urinary disorders
Renal amyloidosis
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
13.6%
3/22 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
7.7%
1/13 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
7.7%
1/13 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
13.0%
3/23 • Number of events 4 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
21.1%
4/19 • Number of events 6 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
9.1%
2/22 • Number of events 2 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Macule
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
6.7%
1/15 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.3%
1/19 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Vascular disorders
Flushing
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
4.5%
1/22 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/23 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/22 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/18 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/19 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
5.6%
1/18 • Number of events 1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/15 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/13 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/1 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
0.00%
0/3 • Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The APaT population was used for safety analysis.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER