Trial Outcomes & Findings for Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers (NCT NCT03515551)
NCT ID: NCT03515551
Last Updated: 2022-03-11
Results Overview
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 35 months
Results posted on
2022-03-11
Participant Flow
The sponsor elected to not proceed with the efficacy determining expansion phase (Phase 2) of IMCnyeso-101 for strategic reasons. Phase 2 data were not collected. As of 25 Mar 2021, further enrollment into the Phase 1 dose escalation phase was discontinued and last patient visit was 10 June 2021. Participants who were receiving study drug were allowed to continue treatment until unacceptable toxicity, disease progression, or other reason to discontinue occurred.
There were a total of 28 unique participants; one participant from the 10 mcg cohort was sequentially enrolled in the 30-100 mcg cohort.
Participant milestones
| Measure |
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
5
|
3
|
5
|
4
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
5
|
3
|
5
|
4
|
5
|
Reasons for withdrawal
| Measure |
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
2
|
2
|
2
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study ended by sponsor
|
0
|
0
|
2
|
1
|
3
|
0
|
3
|
|
Overall Study
Sequential enrollment in 30-100 mcg cohort
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
Baseline characteristics by cohort
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=2 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years old
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
|
Age, Customized
65-84 years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Original cancer diagnosis
Melanoma
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Original cancer diagnosis
Synovial sarcoma
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Original cancer diagnosis
Urothelial carcinoma
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Original cancer diagnosis
Non-small cell lung cancer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 35 monthsPopulation: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose-limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 35 monthsPopulation: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Adverse Events
Any treatment-emergent adverse event (TEAE)
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Phase 1: Number of Participants With Adverse Events
Any TEAE Grade ≥3
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Phase 1: Number of Participants With Adverse Events
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 35 monthsPopulation: The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With No Dose Interruptions or Reductions
No dose interruption at any time
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase 1: Number of Participants With No Dose Interruptions or Reductions
No dose reduction at any time
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures.
Best overall response per RECIST v.1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures.
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The Full Analysis Set includes all participants assigned to treatment who receive at least 1 full or partial dose of study drug and for which evaluation was able to be made for at least 1 post-baseline tumor assessment.
Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1.
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Best Overall Response (BOR)
Progressive Disease
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Phase 1: Number of Participants With Best Overall Response (BOR)
Non-evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Phase 1: Number of Participants With Best Overall Response (BOR)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase 1: Number of Participants With Best Overall Response (BOR)
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase 1: Number of Participants With Best Overall Response (BOR)
Stable Disease
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for this outcome measure in Phase 2.
Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Progression-free Survival
|
1.8 Months
Interval 0.7 to 2.4
|
1.6 Months
Interval 1.2 to 2.1
|
2.1 Months
Interval 1.9 to 7.8
|
1.9 Months
Interval 1.3 to 1.9
|
2.1 Months
Interval 0.8 to 3.8
|
1.8 Months
Interval 0.9 to 2.1
|
1.4 Months
Interval 1.0 to
Not estimable due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; analysis of duration of response was not able to be performed in Phase 1 because no complete or partial responses were observed and no data were collected for Phase 2.
Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for this outcome measure in Phase 2.
Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Overall Survival
|
3.3 Months
Interval 2.1 to 5.9
|
NA Months
Interval 2.2 to
Not estimable due to insufficient number of events
|
NA Months
Interval 3.7 to
Not estimable due to insufficient number of events
|
9.7 Months
Interval 2.3 to
Not estimable due to insufficient number of events
|
NA Months
Interval 5.2 to
Not estimable due to insufficient number of events
|
7.5 Months
Interval 0.9 to 11.7
|
NA Months
Interval 3.7 to
Not estimable due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15Population: The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data.
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=4 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
Cycle 1 Day 1
|
12500 hr*pg/mL
Standard Deviation 6910
|
17700 hr*pg/mL
Standard Deviation 14400
|
132000 hr*pg/mL
Standard Deviation 44600
|
295000 hr*pg/mL
Standard Deviation 72400
|
182000 hr*pg/mL
Standard Deviation 180000
|
78800 hr*pg/mL
Standard Deviation 32500
|
127000 hr*pg/mL
Standard Deviation 53700
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
Cycle 1 Day 15
|
7270 hr*pg/mL
Standard Deviation 4530
|
29500 hr*pg/mL
Standard Deviation 35900
|
149000 hr*pg/mL
Standard Deviation 70500
|
301000 hr*pg/mL
Standard Deviation 223000
|
497000 hr*pg/mL
Standard Deviation 260000
|
611000 hr*pg/mL
Standard Deviation 330000
|
142000 hr*pg/mL
Standard Deviation NA
Insufficient number of participants with evaluable data
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15Population: The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=4 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
Cycle 1 Day 1
|
1130 pg/mL
Standard Deviation 674
|
1530 pg/mL
Standard Deviation 1160
|
6850 pg/mL
Standard Deviation 1110
|
16100 pg/mL
Standard Deviation 961
|
6810 pg/mL
Standard Deviation 5290
|
3890 pg/mL
Standard Deviation 932
|
6710 pg/mL
Standard Deviation 1380
|
—
|
|
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
Cycle 1 Day 15
|
1090 pg/mL
Standard Deviation 634
|
1800 pg/mL
Standard Deviation 1290
|
6220 pg/mL
Standard Deviation 1450
|
17900 pg/mL
Standard Deviation 1910
|
19900 pg/mL
Standard Deviation 3570
|
26900 pg/mL
Standard Deviation 3930
|
65800 pg/mL
Standard Deviation NA
Insufficient number of participants with evaluable data
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15Population: The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=4 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
Cycle 1 Day 15
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
2.00 Hours
Standard Deviation NA
Insufficient number of participants with evaluable data
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax)
Cycle 1 Day 1
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.00 Hours
Standard Deviation 0.00
|
1.67 Hours
Standard Deviation 1.15
|
1.00 Hours
Standard Deviation 0.00
|
1.25 Hours
Standard Deviation 0.50
|
1.00 Hours
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers
Outcome measures
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 Participants
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 Participants
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 Participants
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 Participants
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 Participants
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-IMCnyeso Antibody Formation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
Adverse Events
Phase 1: IMCnyeso 3 mcg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1: IMCnyeso 10 mcg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: IMCnyeso 30 mcg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1: IMCnyeso 100 mcg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: IMCnyeso 30-100 mcg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1: IMCnyeso 30-100-180 mcg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1: IMCnyeso 30-100-300 mcg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 participants at risk
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 participants at risk
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 participants at risk
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 participants at risk
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Injury, poisoning and procedural complications
Overdose
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscular haemorrhage
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
Other adverse events
| Measure |
Phase 1: IMCnyeso 3 mcg
n=4 participants at risk
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 10 mcg
n=3 participants at risk
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30 mcg
n=5 participants at risk
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 100 mcg
n=3 participants at risk
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
|
Phase 1: IMCnyeso 30-100 mcg
n=5 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
|
Phase 1: IMCnyeso 30-100-180 mcg
n=4 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
|
Phase 1: IMCnyeso 30-100-300 mcg
n=5 participants at risk
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
4/4 • Number of events 7 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 6 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 8 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 8 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Eye disorders
Eyelid oedema
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 6 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
50.0%
2/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
50.0%
2/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
80.0%
4/5 • Number of events 11 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
3/3 • Number of events 7 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
5/5 • Number of events 10 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
75.0%
3/4 • Number of events 8 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
5/5 • Number of events 16 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Chills
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 7 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 9 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
75.0%
3/4 • Number of events 10 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 14 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
50.0%
2/4 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Facial pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Feeling cold
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Local swelling
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Malaise
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
General disorders
Pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
75.0%
3/4 • Number of events 6 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
5/5 • Number of events 14 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Viral respiratory tract infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Pharyngitis
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 6 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
50.0%
2/4 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Body temperature increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Breath sounds abnormal
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Heart rate increased
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
3/3 • Number of events 6 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
80.0%
4/5 • Number of events 8 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
100.0%
3/3 • Number of events 7 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
80.0%
4/5 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Neuralgia
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
66.7%
2/3 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
60.0%
3/5 • Number of events 9 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 11 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
33.3%
1/3 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
40.0%
2/5 • Number of events 2 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
20.0%
1/5 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
|
Vascular disorders
Superior vena cava syndrome
|
25.0%
1/4 • Number of events 1 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/3 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/4 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
0.00%
0/5 • Up to 35 months
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place