Trial Outcomes & Findings for KZR-261 in Subjects With Advanced Solid Malignancies (NCT NCT05047536)
NCT ID: NCT05047536
Last Updated: 2025-12-19
Results Overview
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
20 months
Results posted on
2025-12-19
Participant Flow
At the time of study termination, Part 2A of the study had only enrolled participants with melanomas. Part 2B of the study (Dose Optimization) did not occur.
Participant milestones
| Measure |
Dose 1
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
6
|
6
|
6
|
5
|
17
|
8
|
7
|
|
Overall Study
COMPLETED
|
1
|
0
|
1
|
0
|
1
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
6
|
5
|
3
|
4
|
17
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KZR-261 in Subjects With Advanced Solid Malignancies
Baseline characteristics by cohort
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=6 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=7 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 3.6 • n=6 Participants
|
81.4 years
STANDARD_DEVIATION 9.6 • n=6 Participants
|
59.8 years
STANDARD_DEVIATION 13.2 • n=9 Participants
|
67.2 years
STANDARD_DEVIATION 5.0 • n=6 Participants
|
67.3 years
STANDARD_DEVIATION 6.4 • n=195 Participants
|
64.4 years
STANDARD_DEVIATION 7.0 • n=585 Participants
|
67.4 years
STANDARD_DEVIATION 8.8 • n=19829 Participants
|
59.0 years
STANDARD_DEVIATION 12.5 • n=77547 Participants
|
71.3 years
STANDARD_DEVIATION 10.5 • n=39438 Participants
|
66.0 years
STANDARD_DEVIATION 10.0 • n=333664 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=195 Participants
|
5 Participants
n=585 Participants
|
8 Participants
n=19829 Participants
|
5 Participants
n=77547 Participants
|
4 Participants
n=39438 Participants
|
34 Participants
n=333664 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
9 Participants
n=19829 Participants
|
3 Participants
n=77547 Participants
|
3 Participants
n=39438 Participants
|
27 Participants
n=333664 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
2 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
8 Participants
n=333664 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=195 Participants
|
5 Participants
n=585 Participants
|
15 Participants
n=19829 Participants
|
7 Participants
n=77547 Participants
|
7 Participants
n=39438 Participants
|
52 Participants
n=333664 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
3 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
5 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=195 Participants
|
5 Participants
n=585 Participants
|
14 Participants
n=19829 Participants
|
6 Participants
n=77547 Participants
|
7 Participants
n=39438 Participants
|
50 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
2 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
3 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
Zero
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=195 Participants
|
4 Participants
n=585 Participants
|
3 Participants
n=19829 Participants
|
3 Participants
n=77547 Participants
|
4 Participants
n=39438 Participants
|
19 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
One
|
1 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
14 Participants
n=19829 Participants
|
5 Participants
n=77547 Participants
|
3 Participants
n=39438 Participants
|
42 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
Two
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
Three
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
Four
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
ECOG Performance Status at Screening
Not Done
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
0 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Breast
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Cervical
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Colorectal
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
2 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
15 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Esophagus
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Gastric
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
2 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
4 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Head and Neck
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
2 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Lung
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
2 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
6 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Malignant Cutaneous Melanoma
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
5 Participants
n=39438 Participants
|
7 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Malignant Uveal Melanoma
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
2 Participants
n=39438 Participants
|
3 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Mesothelioma
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
1 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Ovarian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
1 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Pancreatic
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
6 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
8 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Prostate
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=585 Participants
|
0 Participants
n=19829 Participants
|
0 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
2 Participants
n=333664 Participants
|
|
Type of Cancer Under Study
Other
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=195 Participants
|
1 Participants
n=585 Participants
|
4 Participants
n=19829 Participants
|
1 Participants
n=77547 Participants
|
0 Participants
n=39438 Participants
|
9 Participants
n=333664 Participants
|
PRIMARY outcome
Timeframe: 20 monthsPopulation: All participants who received at least 1 dose of study treatment (KZR-261).
Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=6 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=7 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Mild (Grade 1)
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Moderate (Grade 2)
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Severe (Grade 3)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
4 participants
|
4 participants
|
1 participants
|
5 participants
|
2 participants
|
0 participants
|
|
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Life-threatening (Grade 4)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
12 participants
|
5 participants
|
5 participants
|
|
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)
Death (Grade 5)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The DLT Evaluable Population consists of all participants who either met the following minimal exposure criteria and have sufficient safety evaluations without having a DLT, or have experienced a DLT during the DLT assessment period. Participants who did not experience a DLT in Dose Escalation must have received all of their scheduled doses (Days 1, 8, and 15) during the DLT assessment period with completed follow-up data available through 28 days of Cycle 1 to be DLT-assessable.
Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=5 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=14 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=5 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing Dose-limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15Population: The PK analyses were performed for all subjects in the PK population (all subjects that received at least one dose plasma KZR-261 concentration measurement during Cycles 1 and 2 of treatment).
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of KZR-261 (Part 1)
Cycle 1, Day 1
|
601.5 ng/mL
Geometric Coefficient of Variation 26.9
|
1414.9 ng/mL
Geometric Coefficient of Variation 1.5
|
1536.1 ng/mL
Geometric Coefficient of Variation 34.7
|
2793.5 ng/mL
Geometric Coefficient of Variation 44.9
|
5126.6 ng/mL
Geometric Coefficient of Variation 37.8
|
7475.8 ng/mL
Geometric Coefficient of Variation 10.9
|
9531.2 ng/mL
Geometric Coefficient of Variation 39.5
|
12159.8 ng/mL
Geometric Coefficient of Variation 27.8
|
16346.5 ng/mL
Geometric Coefficient of Variation 27.4
|
—
|
|
Maximum Plasma Concentration of KZR-261 (Part 1)
Cycle 1, Day 15
|
580.6 ng/mL
Geometric Coefficient of Variation 35.5
|
2160.0 ng/mL
Geometric Coefficient of Variation NA
The measure was only collected for one participant.
|
2413.2 ng/mL
Geometric Coefficient of Variation 46.0
|
4149.8 ng/mL
Geometric Coefficient of Variation 45.6
|
4409.6 ng/mL
Geometric Coefficient of Variation 40.2
|
7571.7 ng/mL
Geometric Coefficient of Variation 23.8
|
11906.8 ng/mL
Geometric Coefficient of Variation 23.6
|
12917.1 ng/mL
Geometric Coefficient of Variation 36.0
|
25955.5 ng/mL
Geometric Coefficient of Variation 154.2
|
—
|
|
Maximum Plasma Concentration of KZR-261 (Part 1)
Cycle 2, Day 1
|
566.5 ng/mL
Geometric Coefficient of Variation 13.3
|
1724.4 ng/mL
Geometric Coefficient of Variation 46.7
|
2406.6 ng/mL
Geometric Coefficient of Variation 57.4
|
3712.8 ng/mL
Geometric Coefficient of Variation 54.5
|
4359.1 ng/mL
Geometric Coefficient of Variation 18.7
|
6686.2 ng/mL
Geometric Coefficient of Variation 21.1
|
14497.6 ng/mL
Geometric Coefficient of Variation 42.2
|
12208.5 ng/mL
Geometric Coefficient of Variation 36.0
|
31491.0 ng/mL
Geometric Coefficient of Variation 260.2
|
—
|
|
Maximum Plasma Concentration of KZR-261 (Part 1)
Cycle 2, Day 15
|
603.2 ng/mL
Geometric Coefficient of Variation 20.7
|
1334.6 ng/mL
Geometric Coefficient of Variation 61.3
|
2128.8 ng/mL
Geometric Coefficient of Variation 36.3
|
3510.7 ng/mL
Geometric Coefficient of Variation 27.5
|
4409.6 ng/mL
Geometric Coefficient of Variation 28.6
|
7343.5 ng/mL
Geometric Coefficient of Variation 24.9
|
12218.5 ng/mL
Geometric Coefficient of Variation 11.0
|
15342.7 ng/mL
Geometric Coefficient of Variation 31.4
|
18300.0 ng/mL
Geometric Coefficient of Variation NA
The measure was only collected for one participant.
|
—
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15Population: The PK analyses were performed for all subjects in the PK population (all subjects that received at least one dose plasma KZR-261 concentration measurement during Cycles 1 and 2 of treatment).
This is the area under the curve (AUC) from predose through postdose observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, and 24 hours post infusion.
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
The Plasma Concentration Time Curve of KZR-261 (Part 1)
Cycle 1, Day 1
|
653.2 hr*ng/mL
Geometric Coefficient of Variation 14.5
|
1483.4 hr*ng/mL
Geometric Coefficient of Variation 101.6
|
2252.7 hr*ng/mL
Geometric Coefficient of Variation 13.7
|
5592.0 hr*ng/mL
Geometric Coefficient of Variation 74.6
|
6427.1 hr*ng/mL
Geometric Coefficient of Variation 30.8
|
9919.2 hr*ng/mL
Geometric Coefficient of Variation 11.1
|
15766.7 hr*ng/mL
Geometric Coefficient of Variation 15.3
|
22918.9 hr*ng/mL
Geometric Coefficient of Variation 45.4
|
34948.3 hr*ng/mL
Geometric Coefficient of Variation 31.7
|
—
|
|
The Plasma Concentration Time Curve of KZR-261 (Part 1)
Cycle 1, Day 15
|
528.6 hr*ng/mL
Geometric Coefficient of Variation 20.5
|
2596.4 hr*ng/mL
Geometric Coefficient of Variation NA
Only one participant had measurements at this timepoint.
|
2511.2 hr*ng/mL
Geometric Coefficient of Variation 42.4
|
4259.1 hr*ng/mL
Geometric Coefficient of Variation 26.4
|
6280.1 hr*ng/mL
Geometric Coefficient of Variation 31.8
|
8944.0 hr*ng/mL
Geometric Coefficient of Variation 16.4
|
14624.8 hr*ng/mL
Geometric Coefficient of Variation 13.9
|
18088.1 hr*ng/mL
Geometric Coefficient of Variation 27.0
|
38084.6 hr*ng/mL
Geometric Coefficient of Variation 96.2
|
—
|
|
The Plasma Concentration Time Curve of KZR-261 (Part 1)
Cycle 2, Day 1
|
532.2 hr*ng/mL
Geometric Coefficient of Variation 2.9
|
1506.8 hr*ng/mL
Geometric Coefficient of Variation 68.2
|
2485.0 hr*ng/mL
Geometric Coefficient of Variation 12.1
|
6536.5 hr*ng/mL
Geometric Coefficient of Variation 80.4
|
7030.0 hr*ng/mL
Geometric Coefficient of Variation 21.6
|
10171.0 hr*ng/mL
Geometric Coefficient of Variation 18.0
|
20581.5 hr*ng/mL
Geometric Coefficient of Variation 36.2
|
20847.3 hr*ng/mL
Geometric Coefficient of Variation 57.6
|
48172.7 hr*ng/mL
Geometric Coefficient of Variation 92.3
|
—
|
|
The Plasma Concentration Time Curve of KZR-261 (Part 1)
Cycle 2, Day 15
|
568.6 hr*ng/mL
Geometric Coefficient of Variation 21.8
|
1304.5 hr*ng/mL
Geometric Coefficient of Variation 78.3
|
2126.4 hr*ng/mL
Geometric Coefficient of Variation 22.7
|
5135.9 hr*ng/mL
Geometric Coefficient of Variation 53.6
|
6246.6 hr*ng/mL
Geometric Coefficient of Variation 28.2
|
8958.0 hr*ng/mL
Geometric Coefficient of Variation 23.2
|
17093.8 hr*ng/mL
Geometric Coefficient of Variation 16.0
|
22390.0 hr*ng/mL
Geometric Coefficient of Variation 31.7
|
37991.6 hr*ng/mL
Geometric Coefficient of Variation NA
Only one participant had measurements at this timepoint.
|
—
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: The Response Evaluable Population is defined as all participants who received at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment.
The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=4 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=5 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=14 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=6 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=6 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response (ORR) Following KZR-261
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: The Response Evaluable Population is defined as all participants who received at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment.
The clinical benefit rate defined as the number of participants achieving a best response of complete response (CR)/partial response (PR) or stable disease over at least 2 consecutive response assessment time points. Stable disease is defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of longest diameters of target lesions while on study.
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=4 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=5 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=14 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=6 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=6 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Participants With Clinical Benefit of Stable Disease Following KZR-261
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 months and 6 monthsPopulation: The Response Evaluable Population is defined as all subjects who receive at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment. For participants who have neither progressed nor died, PFS is censored at the date of the last disease assessment. PFS at 4 months and 6 months are defined as subjects alive and progression-free at 4 months and at 6 months, respectively, after the initiation of study treatment.
The number of participants with progression-free survival (PFS), defined as the date of initiation of study treatment to the date of documented PD or death from any cause, whichever occurs first, at 4 months and 6 months. PFS is based on the number of subjects in each group in the response evaluable population at the specific timepoints (4 or 6 months).
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=4 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=5 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=14 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=6 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=6 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival of Participants Treated With KZR-261
4 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Progression-free Survival of Participants Treated With KZR-261
6 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: The Response Evaluable Population is defined as all participants who received at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment.
Time of overall survival for participants treated with KZR-261.
Outcome measures
| Measure |
Dose 1
n=2 Participants
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 Participants
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=1 Participants
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=5 Participants
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=1 Participants
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=2 Participants
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=2 Participants
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=10 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=2 Participants
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=4 Participants
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival of Participants Treated With KZR-261
|
21.7 weeks
Interval 21.0 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
22.6 weeks
Interval 12.6 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
NA weeks
Interval 15.0 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
17.9 weeks
Interval 8.4 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
NA weeks
Interval 39.7 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
NA weeks
Interval 33.9 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
53.4 weeks
Interval 11.7 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
12.4 weeks
Interval 7.9 to 26.1
|
NA weeks
Interval 9.3 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
24.6 weeks
Interval 19.4 to
NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.
|
Adverse Events
Dose 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose 6
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose 7
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose 8
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Dose 9
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Melanoma Expansion Cohort
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose 1
n=2 participants at risk
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 participants at risk
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 participants at risk
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=6 participants at risk
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 participants at risk
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 participants at risk
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 participants at risk
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 participants at risk
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 participants at risk
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=7 participants at risk
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
Other adverse events
| Measure |
Dose 1
n=2 participants at risk
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 2
n=2 participants at risk
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 3
n=2 participants at risk
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 4
n=6 participants at risk
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 5
n=6 participants at risk
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 6
n=6 participants at risk
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 7
n=5 participants at risk
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 8
n=17 participants at risk
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Dose 9
n=8 participants at risk
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
Melanoma Expansion Cohort
n=7 participants at risk
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
23.5%
4/17 • Number of events 5 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Lipase increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
40.0%
2/5 • Number of events 26 • Through end of study, up to 2.25 years
|
58.8%
10/17 • Number of events 28 • Through end of study, up to 2.25 years
|
37.5%
3/8 • Number of events 6 • Through end of study, up to 2.25 years
|
42.9%
3/7 • Number of events 11 • Through end of study, up to 2.25 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Weight increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 31 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 10 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
28.6%
2/7 • Number of events 6 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
17.6%
3/17 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 3 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 3 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 2 • Through end of study, up to 2.25 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 3 • Through end of study, up to 2.25 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
40.0%
2/5 • Number of events 3 • Through end of study, up to 2.25 years
|
29.4%
5/17 • Number of events 9 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 6 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
40.0%
2/5 • Number of events 3 • Through end of study, up to 2.25 years
|
35.3%
6/17 • Number of events 15 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
28.6%
2/7 • Number of events 6 • Through end of study, up to 2.25 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
28.6%
2/7 • Number of events 2 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 5 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
17.6%
3/17 • Number of events 3 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
23.5%
4/17 • Number of events 4 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 2 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 6 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 5 • Through end of study, up to 2.25 years
|
40.0%
2/5 • Number of events 4 • Through end of study, up to 2.25 years
|
29.4%
5/17 • Number of events 5 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 2 • Through end of study, up to 2.25 years
|
57.1%
4/7 • Number of events 5 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 3 • Through end of study, up to 2.25 years
|
40.0%
2/5 • Number of events 2 • Through end of study, up to 2.25 years
|
35.3%
6/17 • Number of events 6 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
57.1%
4/7 • Number of events 5 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Catheter site rash
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Face oedema
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
66.7%
4/6 • Number of events 4 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
29.4%
5/17 • Number of events 8 • Through end of study, up to 2.25 years
|
37.5%
3/8 • Number of events 4 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Generalised oedema
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Influenza like illness
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Nodule
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Peripheral swelling
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
50.0%
3/6 • Number of events 5 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
23.5%
4/17 • Number of events 4 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 7 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Amylase increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 5 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 8 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 3 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 4 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 2 • Through end of study, up to 2.25 years
|
23.5%
4/17 • Number of events 4 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
25.0%
2/8 • Number of events 2 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
12.5%
1/8 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
50.0%
1/2 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
20.0%
1/5 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
0.00%
0/17 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
14.3%
1/7 • Number of events 1 • Through end of study, up to 2.25 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
33.3%
2/6 • Number of events 2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
16.7%
1/6 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
11.8%
2/17 • Number of events 2 • Through end of study, up to 2.25 years
|
50.0%
4/8 • Number of events 4 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/2 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/6 • Through end of study, up to 2.25 years
|
0.00%
0/5 • Through end of study, up to 2.25 years
|
5.9%
1/17 • Number of events 1 • Through end of study, up to 2.25 years
|
0.00%
0/8 • Through end of study, up to 2.25 years
|
0.00%
0/7 • Through end of study, up to 2.25 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place