Trial Outcomes & Findings for Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension (NCT NCT02587325)
NCT ID: NCT02587325
Last Updated: 2024-11-25
Results Overview
A dose-limiting toxicity (DLT) was defined as a study drug-related Grade ≥3 hematologic AE or persistent intolerable nonhematologic AE of any grade that occurred during the first 4 weeks of treatment, requiring dose reduction or permanent discontinuation of the study drug, in the opinion of the Investigator. The number and percent of patients with a DLT were to be reported by dose cohorts in the Phase 1 dose finding part of the study if any were observed in the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
Nab-Sirolimus Dose Cohort 1
nab-Sirolimus Dose Cohort 1 at 10 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 2
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 3
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 4
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 5
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
|---|---|---|---|---|---|
|
16-Week Dose-finding Safety Part
STARTED
|
4
|
3
|
4
|
3
|
1
|
|
16-Week Dose-finding Safety Part
COMPLETED
|
3
|
3
|
4
|
2
|
1
|
|
16-Week Dose-finding Safety Part
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
|
32-Week Optional Extension Part
STARTED
|
0
|
1
|
4
|
1
|
1
|
|
32-Week Optional Extension Part
COMPLETED
|
0
|
1
|
2
|
1
|
0
|
|
32-Week Optional Extension Part
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nab-Sirolimus Dose Cohort 1
nab-Sirolimus Dose Cohort 1 at 10 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 2
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 3
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 4
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 5
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m\^2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part)
|
|---|---|---|---|---|---|
|
16-Week Dose-finding Safety Part
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
16-Week Dose-finding Safety Part
COVID-19 risk
|
0
|
0
|
0
|
1
|
0
|
|
32-Week Optional Extension Part
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
32-Week Optional Extension Part
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
Baseline characteristics by cohort
| Measure |
Nab-Sirolimus Dose Cohort 1
n=4 Participants
nab-Sirolimus Dose Cohort 1 at 10 mg/m\^2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 2
n=3 Participants
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m\^2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 3
n=4 Participants
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m\^2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 4
n=3 Participants
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m\^2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 5
n=1 Participants
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m\^2, given once weekly intravenously for 16 weeks.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
n=4 Participants
|
45 years
n=3 Participants
|
38.5 years
n=4 Participants
|
45 years
n=3 Participants
|
28 years
n=1 Participants
|
45 years
n=15 Participants
|
|
Sex: Female, Male
16-Week Dose-finding Safety Part · Female
|
3 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
4 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
14 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Sex: Female, Male
16-Week Dose-finding Safety Part · Male
|
1 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Sex: Female, Male
32-Week Optional Extension Part · Female
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
4 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
7 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Sex: Female, Male
32-Week Optional Extension Part · Male
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Ethnicity (NIH/OMB)
16-Week Dose-finding Safety Part · Hispanic or Latino
|
0 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
3 Participants
n=15 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Ethnicity (NIH/OMB)
16-Week Dose-finding Safety Part · Not Hispanic or Latino
|
4 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
2 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
3 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
2 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
12 Participants
n=15 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Ethnicity (NIH/OMB)
16-Week Dose-finding Safety Part · Unknown or Not Reported
|
0 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=3 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=15 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Ethnicity (NIH/OMB)
32-Week Optional Extension Part · Hispanic or Latino
|
0 Participants
15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
2 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
3 Participants
n=7 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Ethnicity (NIH/OMB)
32-Week Optional Extension Part · Not Hispanic or Latino
|
0 Participants
15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
2 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
1 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
4 Participants
n=7 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Ethnicity (NIH/OMB)
32-Week Optional Extension Part · Unknown or Not Reported
|
0 Participants
15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=4 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=1 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
0 Participants
n=7 Participants • 15 patients in the 16-week dose finding part and 7 patients continued to the 32-week optional extension part.
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · American Indian or Alaska Native
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · Asian
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · Black or African American
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · White
|
4 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
14 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · More than one race
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
16-Week Dose-finding Part · Unknown or Not Reported
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · American Indian or Alaska Native
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · Asian
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · Native Hawaiian or Other Pacific Islander
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · Black or African American
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · White
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
3 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
6 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · More than one race
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Race (NIH/OMB)
32-Week Optional Extension Part · Unknown or Not Reported
|
0 Participants
15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
0 Participants
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
1 participants
n=1 Participants
|
15 participants
n=15 Participants
|
|
Body Surface Area
16-Week Dose-finding Safety Part
|
2.1 m^2
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.6 m^2
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.6 m^2
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.8 m^2
n=3 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.8 m^2
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.7 m^2
n=15 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
|
Body Surface Area
32-Week Optional Extension Part
|
—
|
1.5 m^2
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.7 m^2
n=4 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.9 m^2
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.8 m^2
n=1 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
1.8 m^2
n=7 Participants • 15 Patients in the 16-week Dose-Finding Safety Part and 7 continued into the 32-Week Optional Extension Part
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The Treated Population included all patients who received at least 1 dose of nab sirolimus. This population was used for analyses of safety.
A dose-limiting toxicity (DLT) was defined as a study drug-related Grade ≥3 hematologic AE or persistent intolerable nonhematologic AE of any grade that occurred during the first 4 weeks of treatment, requiring dose reduction or permanent discontinuation of the study drug, in the opinion of the Investigator. The number and percent of patients with a DLT were to be reported by dose cohorts in the Phase 1 dose finding part of the study if any were observed in the study.
Outcome measures
| Measure |
Nab-Sirolimus Dose Cohort 1
n=4 Participants
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 2
n=3 Participants
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 3
n=4 Participants
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 4
n=3 Participants
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 5
n=1 Participants
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Overall
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
|---|---|---|---|---|---|---|
|
Dose-limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 17 WeeksPopulation: The Efficacy Evaluable Population included all patients who received at least 1 dose of nab-sirolimus and had at least one post-baseline efficacy assessment. This population was used for analyses of efficacy (N=13).
Median Percent Change from Baseline to Week 17 (after 16 weeks of treatment) in RHC based on Central Lab Analysis (Pulmonary vascular resistance, Cardiac Output, Cardiac Index, Stroke Volume)
Outcome measures
| Measure |
Nab-Sirolimus Dose Cohort 1
n=3 Participants
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 2
n=3 Participants
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 3
n=4 Participants
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 4
n=2 Participants
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 5
n=1 Participants
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Overall
n=13 Participants
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
|---|---|---|---|---|---|---|
|
Right Heart Catheterization Based on Central Lab Analysis (Pulmonary Vascular Resistance, Cardiac Output, Cardiac Index, Stroke Volume)
Pulmonary Vascular Resistance (dyn×sec/cm5)
|
-30.1 percentage of change
Interval -47.8 to -21.8
|
10.9 percentage of change
Interval -20.5 to 18.0
|
-3.5 percentage of change
Interval -40.2 to 14.5
|
-15.7 percentage of change
Interval -33.3 to 1.9
|
-30.8 percentage of change
Interval -30.8 to -30.8
|
-20.5 percentage of change
Interval -47.8 to 18.0
|
|
Right Heart Catheterization Based on Central Lab Analysis (Pulmonary Vascular Resistance, Cardiac Output, Cardiac Index, Stroke Volume)
Thermodilution Cardiac Output Mean (L/minute)
|
40.1 percentage of change
Interval 39.5 to 59.6
|
-15.4 percentage of change
Interval -23.1 to -13.1
|
10.8 percentage of change
Interval -15.6 to 40.1
|
9.6 percentage of change
Interval -9.4 to 28.5
|
27.4 percentage of change
Interval 27.4 to 27.4
|
16.9 percentage of change
Interval -23.1 to 59.6
|
|
Right Heart Catheterization Based on Central Lab Analysis (Pulmonary Vascular Resistance, Cardiac Output, Cardiac Index, Stroke Volume)
Cardiac Index (L/minute/m2)
|
40.1 percentage of change
Interval 39.5 to 66.4
|
-16.5 percentage of change
Interval -17.4 to -12.8
|
13.5 percentage of change
Interval -17.2 to 43.9
|
9.4 percentage of change
Interval -5.7 to 24.5
|
31.2 percentage of change
Interval 31.2 to 31.2
|
21.4 percentage of change
Interval -17.4 to 66.4
|
|
Right Heart Catheterization Based on Central Lab Analysis (Pulmonary Vascular Resistance, Cardiac Output, Cardiac Index, Stroke Volume)
Stroke Volume (mL)
|
11.6 percentage of change
Interval 11.1 to 81.1
|
-14.4 percentage of change
Interval -19.4 to 10.3
|
11.0 percentage of change
Interval -24.6 to 42.3
|
6.3 percentage of change
Interval -14.6 to 27.1
|
10.5 percentage of change
Interval 10.5 to 10.5
|
10.5 percentage of change
Interval -24.6 to 81.1
|
SECONDARY outcome
Timeframe: 17 WeeksPopulation: The Efficacy Evaluable Population included all patients who received at least 1 dose of nab-sirolimus and had at least one post-baseline efficacy assessment. This population was used for analyses of efficacy (N=13).
Median Percent Change from Baseline to Week 17 (after 16 weeks of treatment) in 6MWD
Outcome measures
| Measure |
Nab-Sirolimus Dose Cohort 1
n=3 Participants
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 2
n=3 Participants
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 3
n=4 Participants
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 4
n=2 Participants
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 5
n=1 Participants
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Overall
n=13 Participants
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
|---|---|---|---|---|---|---|
|
6-minute Walk Distance (6MWD)
|
-2.0 percentage of change
Interval -21.0 to 46.6
|
16.0 percentage of change
Interval 3.1 to 37.8
|
13.3 percentage of change
Interval -14.0 to 22.5
|
16.6 percentage of change
Interval 12.3 to 21.0
|
21.0 percentage of change
Interval 21.0 to 21.0
|
15.0 percentage of change
Interval -21.0 to 46.6
|
SECONDARY outcome
Timeframe: 17 WeeksPopulation: The Efficacy Evaluable Population included all patients who received at least 1 dose of nab-sirolimus and had at least one post-baseline efficacy assessment. This population was used for analyses of efficacy (N=12).
Median Percent Change from Baseline to Week 17 (after 16 weeks of treatment) in NT Pro-BNP
Outcome measures
| Measure |
Nab-Sirolimus Dose Cohort 1
n=3 Participants
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 2
n=3 Participants
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 3
n=3 Participants
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 4
n=2 Participants
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Nab-Sirolimus Dose Cohort 5
n=1 Participants
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
Overall
n=12 Participants
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks. The initial 16-Week treatment was followed optionally by up to 32 weeks of therapy (Extension Part).
|
|---|---|---|---|---|---|---|
|
N-terminal Pro-brain Natriuretic Peptide (NT Pro-BNP)
|
-49.0 percentage of change
Interval -65.5 to 79.7
|
-34.6 percentage of change
Interval -73.8 to -4.5
|
-7.1 percentage of change
Interval -62.2 to 18.8
|
-10.8 percentage of change
Interval -21.6 to 0.0
|
-17.0 percentage of change
Interval -17.0 to -17.0
|
-19.3 percentage of change
Interval -73.8 to 79.7
|
Adverse Events
Nab-Sirolimus Dose Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Overall Nab-Sirolimus Dose Cohort 1-5
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 2; 32 Weeks Optional Extension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 3; 32 Weeks Optional Extension
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 4; 32 Weeks Optional Extension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nab-Sirolimus Dose Cohort 5; 32 Weeks Optional Extension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nab-Sirolimus Dose Cohort 1
n=4 participants at risk
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 2
n=3 participants at risk
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 3
n=4 participants at risk
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 4
n=3 participants at risk
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 5
n=1 participants at risk
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks.
|
Overall Nab-Sirolimus Dose Cohort 1-5
n=15 participants at risk
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 2; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 1.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 3; 32 Weeks Optional Extension
n=4 participants at risk
The initial 16-Week treatment at 2.5 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 4; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 5.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 5; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 5.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
6.7%
1/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
6.7%
1/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
6.7%
1/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
Other adverse events
| Measure |
Nab-Sirolimus Dose Cohort 1
n=4 participants at risk
nab-Sirolimus Dose Cohort 1 at 10 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 2
n=3 participants at risk
nab-Sirolimus Dose Cohort 2 at 1.0 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 3
n=4 participants at risk
nab-Sirolimus Dose Cohort 3 at 2.5 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 4
n=3 participants at risk
nab-Sirolimus Dose Cohort 4 at 5.0 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 5
n=1 participants at risk
nab-Sirolimus Dose Cohort 5 at 7.5 mg/m2, given once weekly intravenously for 16 weeks.
|
Overall Nab-Sirolimus Dose Cohort 1-5
n=15 participants at risk
nab-Sirolimus Dose Cohort 1-5 at 1-10 mg/m2, given once weekly intravenously for 16 weeks.
|
Nab-Sirolimus Dose Cohort 2; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 1.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 3; 32 Weeks Optional Extension
n=4 participants at risk
The initial 16-Week treatment at 2.5 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 4; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 5.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
Nab-Sirolimus Dose Cohort 5; 32 Weeks Optional Extension
n=1 participants at risk
The initial 16-Week treatment at 5.0 mg/m2 was followed optionally by up to 32 weeks of therapy (Extension Part)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
66.7%
2/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
46.7%
7/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
3/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
46.7%
7/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
3/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
66.7%
2/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
60.0%
9/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
66.7%
2/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
46.7%
7/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
20.0%
3/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
General disorders
Fatigue
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
66.7%
2/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
5/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
20.0%
3/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
75.0%
3/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Infections and infestations
Rash pustular
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
26.7%
4/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
20.0%
3/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
20.0%
3/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
66.7%
2/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
5/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
20.0%
3/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Blood and lymphatic system disorders
Myelosuppression (Thrombocytopenia)
|
50.0%
2/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
26.7%
4/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
25.0%
1/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
33.3%
1/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
13.3%
2/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/3 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/15 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/4 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
0.00%
0/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
100.0%
1/1 • Adverse Events reported in the initial 16-Week Treatment for all Cohorts 1,2,3,4 & 5 (ie, from baseline through Week 16). Adverse Events reported in the Optional Extension Phase for up to additional 32 weeks of treatment for Cohorts 2, 3, 4, and 5 (ie, Week 17 through 48).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place