Trial Outcomes & Findings for Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas (NCT NCT03660930)
NCT ID: NCT03660930
Last Updated: 2025-04-30
Results Overview
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
First 2 cycles (3-week cycles, 21 days each)
Results posted on
2025-04-30
Participant Flow
No participants were enrolled in Phase II of the study.
Participant milestones
| Measure |
Cohort 1, Dose Level 0
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 4, Dose Level -1
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
0
|
2
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1, Dose Level 0
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 4, Dose Level -1
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
Baseline characteristics by cohort
| Measure |
Cohort 1, Dose Level 0
n=2 Participants
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 4, Dose Level -1
n=2 Participants
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
n=2 Participants
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
n=2 Participants
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
n=2 Participants
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
n=3 Participants
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
n=3 Participants
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
n=3 Participants
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-29
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
30-39
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Age, Customized
50-59
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Age, Customized
60-69
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Age, Customized
70 and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: First 2 cycles (3-week cycles, 21 days each)Population: MTD was determined to be ABI-009 on DAY 1 of a 21 day cycle ONLY in combination with daily oral pazopanib.
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Outcome measures
| Measure |
All Participants
n=19 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose
|
30 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First 2 cycles (3-week cycles, 21 days each)Population: MTD was determined to be ABI-009 on DAY 1 of a 21 day cycle ONLY in combination with daily oral pazopanib.
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Outcome measures
| Measure |
All Participants
n=19 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose
|
400 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First 2 cycles (3-week cycles, 21 days each)A DLT is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-sirolimus and pazopanib. Only toxicities with a clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic AE of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
n=2 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
n=2 Participants
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
n=3 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: First 2 cycles (3 week cycles, 21 days each)A Dose-limiting toxicity is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-Sirolimus or pazopanib. Only toxicities with clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic Ae of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
n=2 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
n=2 Participants
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
n=3 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities
No DLT experienced
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Dose Limiting Toxicities
Thrombocytopenia
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Dose Limiting Toxicities
Neutropenia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose Limiting Toxicities
WBC decreased, Neutropenia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose Limiting Toxicities
Lipase elevated
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose Limiting Toxicities
Proteinuria
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose Limiting Toxicities
Thrombocytopenia, Oral mucositis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose Limiting Toxicities
Thrombocytopenia, Neutropenia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: At 3 monthsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle, with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 where progression is defined as a 20% increase in the sum of the longest diameter of target lesions where the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions. Will be assessed via descriptive statistics.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Rate
|
0.33 proportion of participants
Interval 0.0 to 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose (an average of 41 weeks)Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either nab-sirolimus therapy, pazopanib therapy, or both.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
n=2 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
n=2 Participants
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
n=2 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
n=3 Participants
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
n=3 Participants
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events Profile
Grade 1
|
34 adverse events experienced
|
25 adverse events experienced
|
11 adverse events experienced
|
16 adverse events experienced
|
21 adverse events experienced
|
29 adverse events experienced
|
15 adverse events experienced
|
22 adverse events experienced
|
|
Incidence of Adverse Events Profile
Grade 2
|
30 adverse events experienced
|
22 adverse events experienced
|
6 adverse events experienced
|
16 adverse events experienced
|
22 adverse events experienced
|
34 adverse events experienced
|
8 adverse events experienced
|
15 adverse events experienced
|
|
Incidence of Adverse Events Profile
Grade 4
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
4 adverse events experienced
|
0 adverse events experienced
|
2 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
|
Incidence of Adverse Events Profile
Grade 5
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
0 adverse events experienced
|
|
Incidence of Adverse Events Profile
Grade 3
|
10 adverse events experienced
|
1 adverse events experienced
|
3 adverse events experienced
|
8 adverse events experienced
|
5 adverse events experienced
|
10 adverse events experienced
|
0 adverse events experienced
|
5 adverse events experienced
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be assessed using RECIST v1.1. Will be assessed via descriptive statistics.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Median PFS
|
1.2 months
Interval 0.79 to
The upper bound of the confidence interval is undefined/infinite due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Will be assessed via descriptive statistics.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival Rate
|
0.33 proportion of participants
Interval 0.0 to 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be summarized using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
11.1 months
Interval 5.0 to
The upper bound of the confidence interval is undefined/infinite.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be assessed using descriptive statistics.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
.33 proportion of participants
Interval 0.0 to 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be based on RECIST v1.1. Will be evaluated by CT imaging.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (CR + PR)
|
0.00 proportion of participants
Interval 0.0 to 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 24 weeksPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be based on RECIST v1.1evaluated by computed tomography (CT) imaging. Per RECIST V1.1, Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD])
|
0.33 proportion of participants
Interval 0.0 to 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Three Phase I patients were treated at the recommended Phase II dose of 30 mg/m\^2 nab-sirolimus intravenously on Day 1 of a 21-day cycle with 400 mg of oral daily pazopanib. These three patients were not enrolled in Phase II.
Will be evaluated by CT imaging.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who received at least one dose of ABI-009: either at 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8, 30 mg/m\^2 ABI-009 given intravenously on Day 1 only, or 45 mg/m\^2 of ABI-009 given intravenously on Day 1 only.
|
Cohort 4, Dose Level -1
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 5, Dose Level -2
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib
|
Cohort 6, Dose Level 0B
Subjects received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 9, Dose Level -1B
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 10, Dose Level -2B
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 11, Dose Level 0C
Subjects received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
Cohort 12, Dose Level 1C
Subjects received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response
|
NA months
Since participants did not have a response, we cannot provide duration of response.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1, Dose Level 0
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4, Dose Level -1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5, Dose Level -2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6, Dose Level 0B
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 9, Dose Level -1B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 10, Dose Level -2B
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 11, Dose Level 0C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 12, Dose Level 1C
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Dose Level 0
n=2 participants at risk
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 4, Dose Level -1
n=2 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 5, Dose Level -2
n=2 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 6, Dose Level 0B
n=2 participants at risk
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 9, Dose Level -1B
n=2 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 10, Dose Level -2B
n=3 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 11, Dose Level 0C
n=3 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 12, Dose Level 1C
n=3 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Cardiac disorders
Cardiac disorders, other: Tricuspid valve mass
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
Other adverse events
| Measure |
Cohort 1, Dose Level 0
n=2 participants at risk
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 4, Dose Level -1
n=2 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 5, Dose Level -2
n=2 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 800 mg of pazopanib.
|
Cohort 6, Dose Level 0B
n=2 participants at risk
Participants received 60 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 9, Dose Level -1B
n=2 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 10, Dose Level -2B
n=3 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 and Day 8 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 11, Dose Level 0C
n=3 participants at risk
Participants received 30 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
Cohort 12, Dose Level 1C
n=3 participants at risk
Participants received 45 mg/m\^2 of ABI-009 given intravenously on Day 1 of a 21 day cycle, plus daily oral 400 mg of pazopanib.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Ejection Fraction Decreased
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Platelet Count Decreased
|
100.0%
2/2 • Number of events 16 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 10 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 18 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 11 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Neutrophil Count Decreased
|
50.0%
1/2 • Number of events 7 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 10 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 9 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 6 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 13 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
White Blood Cell Decreased
|
100.0%
2/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Mucositis Oral
|
100.0%
2/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 6 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Lipase Increased
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 6 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Alanine Aminotransferase Increased
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Weight Loss
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Aspartate Aminotransferase Increase
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Non-cardiac Chest Pain
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Creatinine Increased
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
3/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 4 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 7 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 5 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Shingles
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Blood Bilirubin Increased
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Edema Limbs
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Skin Infection
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Eye disorders
Floaters
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Eye disorders
Flashing Lights
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Investigations
Investigations, Other: Platelet Count Increased
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Anal Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Gastrointestinal disorders
Rectal Hemorrage
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall PAin
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other: Palpable bump above Right elbow
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other: Shoulder and neck pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Thrush
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Infections and infestations, other (presumptive viral gastroenteritis - anorexia, nausea, body aches
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Kidney Infection
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Infections and infestations
COVID-19 Infection
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
66.7%
2/3 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Renal and urinary disorders
Hematuria
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Renal and urinary disorders
Proteinurea
|
50.0%
1/2 • Number of events 3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
100.0%
2/2 • Number of events 6 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other: Scalp dermatitis."
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other: peeling of labial skin
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/2 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
0.00%
0/3 • Adverse events are collected continuously from time of consent to 30 days after last dose of study drug (an average of 41 weeks). Duration over which deaths were monitored was from time of consent through study completion, an average of 91 weeks or 21 months.
Systematic assessment of adverse events is completed by regular investigator assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place