Trial Outcomes & Findings for Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (NCT NCT06119217)
NCT ID: NCT06119217
Last Updated: 2026-05-13
Results Overview
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
60
|
68
|
|
Overall Study
COMPLETED
|
66
|
60
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Baseline characteristics by cohort
| Measure |
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=68 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=66 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=60 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2016 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=2016 Participants
|
37 Participants
n=1512 Participants
|
26 Participants
n=504 Participants
|
90 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=2016 Participants
|
29 Participants
n=1512 Participants
|
34 Participants
n=504 Participants
|
104 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=2016 Participants
|
29 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
83 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=2016 Participants
|
37 Participants
n=1512 Participants
|
33 Participants
n=504 Participants
|
111 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=2016 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=2016 Participants
|
19 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
55 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2016 Participants
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=2016 Participants
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=2016 Participants
|
29 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
93 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2016 Participants
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=2016 Participants
|
15 Participants
n=1512 Participants
|
13 Participants
n=504 Participants
|
38 Participants
n=99 Participants
|
|
Region of Enrollment
South Korea
|
11 participants
n=2016 Participants
|
12 participants
n=1512 Participants
|
10 participants
n=504 Participants
|
33 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=2016 Participants
|
29 participants
n=1512 Participants
|
23 participants
n=504 Participants
|
83 participants
n=99 Participants
|
|
Region of Enrollment
Taiwan
|
6 participants
n=2016 Participants
|
4 participants
n=1512 Participants
|
7 participants
n=504 Participants
|
17 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=2016 Participants
|
3 participants
n=1512 Participants
|
6 participants
n=504 Participants
|
13 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=2016 Participants
|
2 participants
n=1512 Participants
|
1 participants
n=504 Participants
|
3 participants
n=99 Participants
|
|
Region of Enrollment
France
|
5 participants
n=2016 Participants
|
7 participants
n=1512 Participants
|
5 participants
n=504 Participants
|
17 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=2016 Participants
|
9 participants
n=1512 Participants
|
8 participants
n=504 Participants
|
28 participants
n=99 Participants
|
|
Body Mass Index
|
25.09 kg/m^2
STANDARD_DEVIATION 4.433 • n=2016 Participants
|
23.50 kg/m^2
STANDARD_DEVIATION 4.169 • n=1512 Participants
|
23.57 kg/m^2
STANDARD_DEVIATION 4.393 • n=504 Participants
|
24.07 kg/m^2
STANDARD_DEVIATION 4.371 • n=99 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Biomarker enriched participants
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first
Outcome measures
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=45 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=32 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=48 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) - Biomarker Enriched Population
|
5.5 months
Interval 3.7 to 7.3
|
7.3 months
Interval 3.6 to 9.7
|
5.9 months
Interval 3.6 to 9.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Intention to treat population (overall)
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=66 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=60 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=68 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) - Overall Population
|
5.5 months
Interval 3.7 to 7.2
|
7.3 months
Interval 5.4 to 9.9
|
5.7 months
Interval 3.6 to 7.4
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Biomarker Enriched Population
Objective response rate (ORR) is defined as the proportion of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) as assessed by the investigators per RECIST v1.1. The BOR is the best response (in the order of CR, PR, stable disease \[SD\], and progressive disease \[PD\]) documented from the date of randomization until the end of study, first disease progression, death, or start of new anti-cancer therapy, or last documented assessment before ≥2 consecutive missing tumor assessments, whichever is earlier.
Outcome measures
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=45 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=32 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=48 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Objective Response Rate (ORR) - Biomarker Enriched Population
|
0.36 proportion
Interval 0.22 to 0.51
|
0.38 proportion
Interval 0.21 to 0.56
|
0.42 proportion
Interval 0.28 to 0.57
|
SECONDARY outcome
Timeframe: Through study completionPopulation: ITT Analysis - Biomarker enriched
OS is defined as the time from randomization until death due to any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Outcome measure is the Kaplan-Meier estimate of OS rate at 12 months.
Outcome measures
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=45 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=32 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=48 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Overall Survival (OS) - Biomarker Enriched Population
|
0.48 proportion
Interval 0.32 to 0.62
|
0.40 proportion
Interval 0.22 to 0.57
|
0.46 proportion
Interval 0.31 to 0.6
|
SECONDARY outcome
Timeframe: Through study completion, up to a max of 2 yearsPopulation: All participants who received any study treatment.
Number of treatment emergent adverse events in all participants who received any dose of study treatment.
Outcome measures
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=66 Participants
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=60 Participants
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=68 Participants
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
64 Number of Participants with TEAEs
|
59 Number of Participants with TEAEs
|
63 Number of Participants with TEAEs
|
Adverse Events
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
Serious events: 38 serious events
Other events: 64 other events
Deaths: 36 deaths
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
Serious events: 40 serious events
Other events: 59 other events
Deaths: 33 deaths
Arm 3 - Nab-Paclitaxel and Gemcitabine
Serious events: 29 serious events
Other events: 63 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=66 participants at risk
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=60 participants at risk
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=68 participants at risk
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Congenital, familial and genetic disorders
Haemophilia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Eye disorders
Retinal tear
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Pyrexia
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Asthenia
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Pain
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Fatigue
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
2.9%
2/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Sepsis
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
2.9%
2/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Covid-19
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Bacteraemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Septic shock
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
2.9%
2/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Embolic stroke
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Product Issues
Device dislocation
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Product Issues
Device leakage
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Product Issues
Device malfunction
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
2.9%
2/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
0.00%
0/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
Other adverse events
| Measure |
Arm 1 - TTX-030 Plus Nab-paclitaxel and Gemcitabine
n=66 participants at risk
Participants in Arm 1 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 2 - TTX-030 Plus Budigalimab Plus Nab-paclitaxel and Gemcitabine
n=60 participants at risk
Participants in Arm 2 were administered IV TTX-030 at a dose of 40 mg/kg at C1D1, then 20 mg/kg Q2W from C1D15 plus budigalimab at a dose of 250 mg (Q2W) on Day 1 and Day 15, plus gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
Arm 3 - Nab-Paclitaxel and Gemcitabine
n=68 participants at risk
Participants in Arm 3 were administered with gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, and 15 each 28-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
43.9%
29/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
50.0%
30/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
45.6%
31/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.4%
28/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
48.3%
29/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
45.6%
31/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
43.9%
29/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
46.7%
28/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
32.4%
22/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Fatigue
|
39.4%
26/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
43.3%
26/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
33.8%
23/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Asthenia
|
31.8%
21/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
35.0%
21/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
27.9%
19/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Decreased appetite
|
30.3%
20/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
35.0%
21/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.5%
16/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
31.8%
21/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
35.0%
21/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
20.6%
14/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
33.3%
22/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
28.3%
17/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.5%
16/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.8%
17/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
28.3%
17/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
27.9%
19/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.8%
17/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
31.7%
19/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
22.1%
15/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
24.2%
16/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
28.3%
17/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.5%
16/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Pyrexia
|
21.2%
14/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
36.7%
22/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
17.6%
12/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
22.7%
15/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.3%
14/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.5%
16/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.7%
15/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
25.0%
15/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
22.1%
15/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
14/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
21.7%
13/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
25.0%
17/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.1%
8/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.3%
14/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
30.9%
21/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
18.2%
12/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
26.7%
16/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
20.6%
14/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
11/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
28.3%
17/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.7%
13/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
16.7%
10/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
17.6%
12/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
23.3%
14/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
17.6%
12/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
18.3%
11/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
14.7%
10/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Headache
|
16.7%
11/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Dysgeusia
|
18.2%
12/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
15.2%
10/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.8%
8/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.6%
5/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
15.0%
9/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.2%
9/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Weight decreased
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.3%
8/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
9/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Hypokalaemia
|
15.2%
10/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.3%
8/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.8%
6/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.2%
9/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.2%
9/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
9/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.8%
8/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
7/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
General disorders
Chills
|
7.6%
5/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
13.2%
9/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.8%
8/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
9.1%
6/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
12.1%
8/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Blood alkaline phosphatase increased
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.3%
5/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.8%
6/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.8%
6/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
3/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
11.7%
7/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.5%
1/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
7.6%
5/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
7.4%
5/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.0%
6/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Investigations
Hypoalbuminaemia
|
7.6%
5/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Nervous system disorders
Paraesthesia
|
7.6%
5/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
6.7%
4/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
2.9%
2/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
4.4%
3/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Gastrointestinal disorders
Blood bilirubin increased
|
6.1%
4/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
3.3%
2/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.9%
4/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
3.0%
2/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
1.7%
1/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
10.3%
7/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/66 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
5.0%
3/60 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
8.8%
6/68 • Through 30 days after the last dose of study treatment, up to a maximum of 2 years.
Adverse events reported following initiation of treatment through 30 days following last dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place