Trial Outcomes & Findings for A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH (NCT NCT02352493)
NCT ID: NCT02352493
Last Updated: 2020-03-30
Results Overview
Adverse events were reported for single-ascending doses (SAD) or multiple ascending doses (MAD) of ALN-CC5 when administered to healthy adult subjects and of multiple doses (MD) in patients with paroxysmal nocturnal hemoglobinuria (PNH)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Part A: through day 658; Part B: through day 532; Part C: through day 280
Results posted on
2020-03-30
Participant Flow
A total of 62 subjects who met eligibility criteria were enrolled. Part A includes all Groups receiving a Single Ascending Dose of study drug; Part B includes all Groups receiving Multiple Ascending Doses of study drug; Part C includes the "ALN-CC5 Multiple Dose - Eculizumab Treated" and "ALN-CC5 Multiple Dose - Eculizumab Naive" Groups.
Participant milestones
| Measure |
Placebo - Single Ascending Dose
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
8
|
3
|
3
|
3
|
3
|
3
|
2
|
3
|
1
|
5
|
3
|
3
|
2
|
1
|
2
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo - Single Ascending Dose
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
Baseline characteristics by cohort
| Measure |
Placebo - Single Ascending Dose
n=8 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 Participants
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 Participants
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
62 Participants
n=667 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
24 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
33 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
22 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
27 years
STANDARD_DEVIATION 5.0 • n=21 Participants
|
23 years
STANDARD_DEVIATION 3.8 • n=8 Participants
|
30 years
STANDARD_DEVIATION 6.7 • n=8 Participants
|
30 years
STANDARD_DEVIATION 8.0 • n=24 Participants
|
27 years
STANDARD_DEVIATION 5.6 • n=42 Participants
|
27 years
STANDARD_DEVIATION 6.3 • n=42 Participants
|
32 years
STANDARD_DEVIATION 7.6 • n=42 Participants
|
29 years
STANDARD_DEVIATION 3.1 • n=42 Participants
|
27 years
STANDARD_DEVIATION 2.9 • n=36 Participants
|
29 years
STANDARD_DEVIATION 4.2 • n=36 Participants
|
26 years
STANDARD_DEVIATION 3.8 • n=24 Participants
|
23 years
STANDARD_DEVIATION 6.1 • n=135 Participants
|
44 years
STANDARD_DEVIATION 16.9 • n=136 Participants
|
44 years
STANDARD_DEVIATION 11.9 • n=44 Participants
|
28.6 years
STANDARD_DEVIATION 8.12 • n=667 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
24 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
38 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
15 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
39 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Part A: through day 658; Part B: through day 532; Part C: through day 280Adverse events were reported for single-ascending doses (SAD) or multiple ascending doses (MAD) of ALN-CC5 when administered to healthy adult subjects and of multiple doses (MD) in patients with paroxysmal nocturnal hemoglobinuria (PNH)
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=8 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 Participants
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 Participants
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
At least 1 Treatment Emergent Adverse Event (TEAE)
|
6 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
At least 1 Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
At least 1 TEAE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part A: through day 70; Part B: through day 140; Part C: through day 140Complement activity was measured in serum samples collected at timepoints throughout the study using the CAP ELISA assay. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in CAP from baseline.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=8 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 Participants
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 Participants
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in Complement Alternative Pathway (CAP)
|
18.823 percentage reduction
Standard Error 4.3020
|
49.321 percentage reduction
Standard Error 5.6718
|
26.337 percentage reduction
Standard Error 5.2159
|
64.435 percentage reduction
Standard Error 2.3138
|
47.628 percentage reduction
Standard Error 3.1740
|
58.525 percentage reduction
Standard Error 5.5782
|
72.517 percentage reduction
Standard Error 7.5442
|
58.914 percentage reduction
Standard Error 13.0568
|
66.097 percentage reduction
Standard Error 7.6113
|
25.419 percentage reduction
Standard Error 5.9153
|
63.224 percentage reduction
Standard Error 4.5313
|
78.028 percentage reduction
Standard Error 5.6692
|
70.618 percentage reduction
Standard Error 6.7831
|
68.367 percentage reduction
Standard Error 0.9750
|
77.079 percentage reduction
Standard Error 1.4564
|
76.470 percentage reduction
Standard Error 8.1563
|
25.951 percentage reduction
Standard Error 25.1389
|
77.558 percentage reduction
Standard Error 5.9434
|
SECONDARY outcome
Timeframe: Part A: through day 70; Part B: through day 140; Part C: through day 140Complement activity was measured in serum samples collected at time points throughout the study using the CCP ELISA assay. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in CCP from baseline.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=8 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 Participants
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 Participants
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in Complement Classical Pathway (CCP)
|
18.417 percentage reduction
Standard Error 2.7684
|
46.953 percentage reduction
Standard Error 2.8152
|
43.615 percentage reduction
Standard Error 6.0458
|
72.939 percentage reduction
Standard Error 3.4838
|
63.582 percentage reduction
Standard Error 2.5038
|
72.809 percentage reduction
Standard Error 1.5589
|
87.307 percentage reduction
Standard Error 1.3750
|
70.830 percentage reduction
Standard Error 11.7722
|
80.646 percentage reduction
Standard Error 4.2849
|
25.419 percentage reduction
Standard Error 6.2753
|
72.340 percentage reduction
Standard Error 3.4211
|
86.031 percentage reduction
Standard Error 4.1209
|
88.821 percentage reduction
Standard Error 6.3222
|
80.126 percentage reduction
Standard Error 1.6075
|
89.145 percentage reduction
Standard Error 1.9147
|
75.938 percentage reduction
Standard Error 7.2788
|
21.333 percentage reduction
Standard Error 20.2816
|
87.606 percentage reduction
Standard Error 4.9981
|
SECONDARY outcome
Timeframe: Part A: through day 70; Part B: through day 140; Part C: through day 140Total C5 protein levels were measured in serum samples collected at time points throughout the study using a mass spectrometry-based method. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in C5 protein level from baseline.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=8 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 Participants
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 Participants
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in C5 Protein Levels
|
15.88 percentage reduction
Standard Error 2.610
|
77.61 percentage reduction
Standard Error 3.249
|
73.44 percentage reduction
Standard Error 2.885
|
93.17 percentage reduction
Standard Error 0.898
|
88.62 percentage reduction
Standard Error 0.565
|
94.60 percentage reduction
Standard Error 1.378
|
97.62 percentage reduction
Standard Error 0.902
|
95.47 percentage reduction
Standard Error 0.306
|
97.49 percentage reduction
Standard Error 0.252
|
24.302 percentage reduction
Standard Error 5.9546
|
94.959 percentage reduction
Standard Error 0.6087
|
98.297 percentage reduction
Standard Error 0.4901
|
98.428 percentage reduction
Standard Error 0.2000
|
98.695 percentage reduction
Standard Error 0.1612
|
98.683 percentage reduction
Standard Error 0.3165
|
96.870 percentage reduction
Standard Error 1.8851
|
96.057 percentage reduction
Standard Error 1.3728
|
98.187 percentage reduction
Standard Error 0.2586
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Maximum observed plasma concentration (Cmax) of ALN-CC5 (cemdisiran) 25-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: Cmax (25-mer)
|
14.4 ng/mL
Standard Deviation 2.33
|
13.5 ng/mL
Standard Deviation 4.38
|
69.8 ng/mL
Standard Deviation 22.8
|
93.9 ng/mL
Standard Deviation 30.8
|
111 ng/mL
Standard Deviation 6.56
|
166 ng/mL
Standard Deviation 42.7
|
217 ng/mL
Standard Deviation 73.1
|
261 ng/mL
Standard Deviation 79.5
|
21.0 ng/mL
Standard Deviation 2.62
|
31.5 ng/mL
Standard Deviation 7.64
|
81.2 ng/mL
Standard Deviation 16.9
|
283 ng/mL
Standard Deviation 17.0
|
61.7 ng/mL
Standard Deviation 24.1
|
47.3 ng/mL
Standard Deviation 16.4
|
74.1 ng/mL
Standard Deviation 22.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Maximum observed plasma concentration (Cmax) of ALN-CC5 (cemdisiran) 23-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: Cmax (23-mer)
|
27.2 ng/mL
Standard Deviation 4.35
|
30.4 ng/mL
Standard Deviation 4.21
|
144 ng/mL
Standard Deviation 39.1
|
178 ng/mL
Standard Deviation 38.1
|
384 ng/mL
Standard Deviation 183
|
787 ng/mL
Standard Deviation 473
|
710 ng/mL
Standard Deviation 250
|
1500 ng/mL
Standard Deviation 966
|
32.0 ng/mL
Standard Deviation 15.4
|
44.7 ng/mL
Standard Deviation 18.1
|
178 ng/mL
Standard Deviation 17.9
|
1080 ng/mL
Standard Deviation 243
|
167 ng/mL
Standard Deviation 41.0
|
103 ng/mL
Standard Deviation 8.48
|
242 ng/mL
Standard Deviation 78.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Time of maximum observed plasma concentration (T max) of ALN-CC5 (cemdisiran) 25-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: T Max (25-mer)
|
0.50 hr
Interval 0.5 to 0.5
|
0.50 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.5 to 0.5
|
0.50 hr
Interval 0.5 to 0.5
|
0.50 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.5 to 0.5
|
1.00 hr
Interval 0.5 to 1.0
|
1.00 hr
Interval 1.0 to 1.0
|
1.0 hr
Interval 1.0 to 1.0
|
1.0 hr
Interval 1.0 to 1.0
|
0.75 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.5 to 1.0
|
1.00 hr
Interval 0.5 to 1.0
|
1.00 hr
Interval 0.5 to 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Time of maximum observed plasma concentration (T max) of ALN-CC5 (cemdisiran) 23-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: T Max (23-mer)
|
8.00 hr
Interval 6.0 to 12.0
|
8.00 hr
Interval 4.0 to 8.0
|
8.00 hr
Interval 8.0 to 8.02
|
6.00 hr
Interval 6.0 to 8.0
|
12.00 hr
Interval 4.0 to 12.02
|
4.00 hr
Interval 4.0 to 8.0
|
1.00 hr
Interval 0.5 to 12.0
|
6.00 hr
Interval 4.0 to 8.0
|
1.00 hr
Interval 1.0 to 1.0
|
1.00 hr
Interval 1.0 to 1.0
|
1.00 hr
Interval 1.0 to 1.0
|
7.00 hr
Interval 6.0 to 8.0
|
4.00 hr
Interval 0.5 to 12.0
|
8.00 hr
Interval 8.0 to 8.0
|
7.55 hr
Interval 5.93 to 9.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Area under the plasma concentration-time curve over the dosing interval zero to time (AUC 0-t) of ALN-CC5 (cemdisiran) 25-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: AUC 0-t (25-mer)
|
6.63 h*ng/mL
Standard Deviation 3.71
|
7.50 h*ng/mL
Standard Deviation 4.65
|
182 h*ng/mL
Standard Deviation 101
|
198 h*ng/mL
Standard Deviation 113
|
287 h*ng/mL
Standard Deviation 67.2
|
574 h*ng/mL
Standard Deviation 15.6
|
444 h*ng/mL
Standard Deviation 78.2
|
757 h*ng/mL
Standard Deviation 154
|
10.5 h*ng/mL
Standard Deviation 1.31
|
15.8 h*ng/mL
Standard Deviation 3.82
|
40.6 h*ng/mL
Standard Deviation 8.44
|
843 h*ng/mL
Standard Deviation 472
|
110 h*ng/mL
Standard Deviation 11.6
|
93.5 h*ng/mL
Standard Deviation 60.7
|
203 h*ng/mL
Standard Deviation 51.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84Population: All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.
Area under the plasma concentration-time curve over the dosing interval zero to time (AUC 0-t) of ALN-CC5 (cemdisiran) 23-mer.
Outcome measures
| Measure |
Placebo - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 Participants
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 Participants
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=2 Participants
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 Participants
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=2 Participants
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Effect of ALN-CC5: AUC 0-t (23-mer)
|
258 h*ng/mL
Standard Deviation 58.6
|
277 h*ng/mL
Standard Deviation 40.9
|
2290 h*ng/mL
Standard Deviation 362
|
2470 h*ng/mL
Standard Deviation 505
|
5450 h*ng/mL
Standard Deviation 1630
|
10040 h*ng/mL
Standard Deviation 3200
|
9720 h*ng/mL
Standard Deviation 2260
|
21540 h*ng/mL
Standard Deviation 9930
|
16.0 h*ng/mL
Standard Deviation 7.71
|
22.3 h*ng/mL
Standard Deviation 9.03
|
88.8 h*ng/mL
Standard Deviation 8.95
|
14520 h*ng/mL
Standard Deviation 2290
|
2420 h*ng/mL
Standard Deviation 668
|
1700 h*ng/mL
Standard Deviation 219
|
2930 h*ng/mL
Standard Deviation 13.0
|
—
|
—
|
—
|
Adverse Events
Placebo - Single Ascending Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ALN-CC5 50mg - Single Ascending Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ALN-CC5 50mg (Japanese) - Single Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 200mg - Single Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALN-CC5 200mg (Japanese) - Single Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALN-CC5 400mg - Single Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 600mg - Single Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 600mg (Japanese) - Single Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALN-CC5 900mg - Single Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ALN-CC5 100mg Weekly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALN-CC5 200mg Weekly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 400mg Weekly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 Multiple Dose - Eculizumab Treated
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ALN-CC5 Multiple Dose - Eculizumab Naive
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - Single Ascending Dose
n=8 participants at risk
Healthy volunteers received a single dose of placebo (normal saline)
|
ALN-CC5 50mg - Single Ascending Dose
n=3 participants at risk
Healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 50mg (Japanese) - Single Ascending Dose
n=3 participants at risk
Japanese healthy volunteers received a single dose of ALN-CC5 50mg
|
ALN-CC5 200mg - Single Ascending Dose
n=3 participants at risk
Healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 200mg (Japanese) - Single Ascending Dose
n=3 participants at risk
Japanese healthy volunteers received a single dose of ALN-CC5 200mg
|
ALN-CC5 400mg - Single Ascending Dose
n=3 participants at risk
Healthy volunteers received a single dose of ALN-CC5 400mg
|
ALN-CC5 600mg - Single Ascending Dose
n=3 participants at risk
Healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 600mg (Japanese) - Single Ascending Dose
n=3 participants at risk
Japanese healthy volunteers received a single dose of ALN-CC5 600mg
|
ALN-CC5 900mg - Single Ascending Dose
n=3 participants at risk
Healthy volunteers received a single dose of ALN-CC5 900mg
|
Placebo - Multiple Ascending Dose
n=6 participants at risk
Healthy volunteers received multiple doses of placebo (normal saline) per corresponding active drug regimen
|
ALN-CC5 100mg Weekly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received weekly doses of ALN-CC5 100mg for 5 doses
|
ALN-CC5 200mg Weekly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses
|
ALN-CC5 400mg Weekly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received weekly doses of ALN-CC5 400mg for 5 doses
|
ALN-CC5 600mg Biweekly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received biweekly doses of ALN-CC5 600mg for 7 doses
|
ALN-CC5 200mg Weekly/Biweekly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by biweekly doses of 200mg for 4 doses
|
ALN-CC5 200mg Weekly/Monthly - Multiple Ascending Dose
n=3 participants at risk
Healthy volunteers received weekly doses of ALN-CC5 200mg for 5 doses followed by monthly doses of 200mg for 2 doses
|
ALN-CC5 Multiple Dose - Eculizumab Treated
n=3 participants at risk
Patients received weekly doses of ALN-CC5 200mg or ALN-CC5 400mg for up to 12 weeks concomitantly with eculizumab
|
ALN-CC5 Multiple Dose - Eculizumab Naive
n=3 participants at risk
Patients naive to eculizumab received weekly doses of ALN-CC5 400mg for 8 doses or weekly doses of ALN-CC5 200mg for 13 doses followed by weekly doses of ALN-CC5 400mg for 4 doses
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site pain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site rash
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site oedema
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Fatigue
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site bruising
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Injection site discomfort
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Injury, poisoning and procedural complications
Tendon injury
|
12.5%
1/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Investigations
Amylase increased
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
2/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Eye disorders
Eye pruritus
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Toothache
|
37.5%
3/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Renal and urinary disorders
Choluria
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Nasopharyngitis
|
37.5%
3/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
4/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
100.0%
3/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
66.7%
2/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
16.7%
1/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Eye disorders
Eye discharge
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Eye disorders
Eye swelling
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Injury, poisoning and procedural complications
Head injury
|
12.5%
1/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/6 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
33.3%
1/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
0.00%
0/3 • Part A: through day 658; Part B: through day 532; Part C: through day 280
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60