Trial Outcomes & Findings for This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. (NCT NCT03573544)
NCT ID: NCT03573544
Last Updated: 2024-02-22
Results Overview
Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Results posted on
2024-02-22
Participant Flow
Participant milestones
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
6
|
8
|
7
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
6
|
8
|
7
|
8
|
9
|
8
|
Reasons for withdrawal
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
1
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Disease progression
|
3
|
3
|
6
|
4
|
5
|
7
|
6
|
7
|
Baseline Characteristics
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Baseline characteristics by cohort
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
n=5 Participants
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
n=3 Participants
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
n=6 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
n=7 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
n=9 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12.86 • n=99 Participants
|
57.7 years
STANDARD_DEVIATION 9.45 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
63.8 years
STANDARD_DEVIATION 13.29 • n=157 Participants
|
57.4 years
STANDARD_DEVIATION 9.36 • n=390 Participants
|
64.9 years
STANDARD_DEVIATION 9.69 • n=16 Participants
|
52.9 years
STANDARD_DEVIATION 14.84 • n=3 Participants
|
60.6 years
STANDARD_DEVIATION 8.07 • n=6 Participants
|
59.8 years
STANDARD_DEVIATION 11.81 • n=114 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
27 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
5 Participants
n=16 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
27 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
7 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
9 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
29 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (NIH/OMB) · Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (NIH/OMB) · Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (NIH/OMB) · East Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
7 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
19 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (NIH/OMB) · Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
8 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Ethnicity (NIH/OMB) · Unknown or not reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.
Outcome measures
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
n=5 Participants
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
n=3 Participants
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
n=6 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
n=7 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
n=9 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
n=8 Participants
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CR, PR, SD) (%)
|
20 Percentage
Interval 0.5 to 71.6
|
66.7 Percentage
Interval 9.4 to 99.2
|
16.7 Percentage
Interval 0.4 to 64.1
|
12.5 Percentage
Interval 0.3 to 52.7
|
14.3 Percentage
Interval 0.4 to 57.9
|
25 Percentage
Interval 3.2 to 65.1
|
22.2 Percentage
Interval 2.8 to 60.0
|
25 Percentage
Interval 3.2 to 65.1
|
Adverse Events
Part A, Dose Escalation - OBI-888 5 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A, Dose Escalation - OBI-888 10 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Dose Escalation - OBI-888 20 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B, Cohort Expansion - Cohort 1, Pancreatic
Serious events: 8 serious events
Other events: 8 other events
Deaths: 1 deaths
Part B, Cohort Expansion - Cohort 2, Esophageal
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B, Cohort Expansion - Cohort 3, Gastric
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B, Cohort Expansion - Cohort 4, Colorectal
Serious events: 5 serious events
Other events: 9 other events
Deaths: 1 deaths
Part B, Cohort Expansion - Cohort 5, Basket
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
n=5 participants at risk
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
n=3 participants at risk
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
n=6 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
n=7 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
n=9 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Infections and infestations
Bacteremia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Infections and infestations
Cellulitis
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Vascular disorders
Shock
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
Other adverse events
| Measure |
Part A, Dose Escalation - OBI-888 5 mg/kg
n=5 participants at risk
OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 10 mg/kg
n=3 participants at risk
OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part A, Dose Escalation - OBI-888 20 mg/kg
n=6 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 2, Esophageal
n=7 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 3, Gastric
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 4, Colorectal
n=9 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
Part B, Cohort Expansion - Cohort 5, Basket
n=8 participants at risk
OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
3/9 • Number of events 6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
50.0%
4/8 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
50.0%
4/8 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Chills
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Asthenia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
General disorders
Peripheral swelling
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.0%
3/5 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
2/5 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
37.5%
3/8 • Number of events 6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
28.6%
2/7 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/9 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
25.0%
2/8 • Number of events 2 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Renal and urinary disorders
Renal failure
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/3 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/6 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/7 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
22.2%
2/9 • Number of events 4 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/8 • Adverse event data were collected through 12 months
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
Additional Information
Dr. Wayne Saville, Chief Medical Officer
OBI Pharma, Inc.
Phone: 619-537-7821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place