Trial Outcomes & Findings for Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors (NCT NCT04084366)
NCT ID: NCT04084366
Last Updated: 2025-03-26
Results Overview
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
Part A, Dose Escalation - OBI-999 0.4 mg/kg
OBI-999 0.4 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 0.8 mg/kg
OBI-999 0.8 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.2 mg/kg
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.6 mg/kg
OBI-999 1.6 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
11
|
10
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
3
|
10
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part A, Dose Escalation - OBI-999 0.4 mg/kg
n=3 Participants
OBI-999 0.4 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 0.8 mg/kg
n=3 Participants
OBI-999 0.8 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.2 mg/kg
n=6 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.6 mg/kg
n=3 Participants
OBI-999 1.6 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=11 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
n=10 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
n=8 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 16.44 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 5.13 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 18.9 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 11.48 • n=21 Participants
|
59.6 years
STANDARD_DEVIATION 10.66 • n=8 Participants
|
62.9 years
STANDARD_DEVIATION 8.15 • n=8 Participants
|
60.2 years
STANDARD_DEVIATION 11.05 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race (custom) · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
9 participants
n=8 Participants
|
6 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
1 participants
n=8 Participants
|
2 participants
n=8 Participants
|
7 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs firstPopulation: The efficacy population consists of all patients who are enrolled, have received at least 1 dose of study drug, and had at least one follow-up tumor assessment scan.
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.
Outcome measures
| Measure |
Part A, Dose Escalation - OBI-999 0.4 mg/kg
n=3 Participants
OBI-999 0.4 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 0.8 mg/kg
n=3 Participants
OBI-999 0.8 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.2 mg/kg
n=6 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.6 mg/kg
n=3 Participants
OBI-999 1.6 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=7 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
n=8 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
n=8 Participants
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (CR+PR)
|
0 % of participants
Interval 0.0 to 70.8
|
0 % of participants
Interval 0.0 to 70.8
|
0 % of participants
Interval 0.0 to 45.9
|
0 % of participants
Interval 0.0 to 70.8
|
0 % of participants
Interval 0.0 to 41.0
|
0 % of participants
Interval 0.0 to 36.9
|
0 % of participants
Interval 0.0 to 36.9
|
Adverse Events
Part A, Dose Escalation - OBI-999 0.4 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part A, Dose Escalation - OBI-999 0.8 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part A, Dose Escalation - OBI-999 1.2 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A, Dose Escalation - OBI-999 1.6 mg/kg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Part B, Cohort Expansion - Cohort 1, Pancreatic
Serious events: 8 serious events
Other events: 10 other events
Deaths: 3 deaths
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A, Dose Escalation - OBI-999 0.4 mg/kg
n=3 participants at risk
OBI-999 0.4 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 0.8 mg/kg
n=3 participants at risk
OBI-999 0.8 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.2 mg/kg
n=6 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.6 mg/kg
n=3 participants at risk
OBI-999 1.6 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=11 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
n=10 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
n=8 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Small intestinal obstruction
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Diarrhea
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Pancreatitis
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Rectal obstruction
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Klebsiella sepsis
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Septic shock
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Sinusitis
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Neutropenia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
100.0%
3/3 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Febrile neutropenia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Dyspnea
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Sinus pain
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Biliary obstruction
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Myalgia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Pathological fracture
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Dehydration
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Pericardial effusion
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Spinal fracture
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Spinal cord compression
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Hypotension
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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-999 0.4 mg/kg
n=3 participants at risk
OBI-999 0.4 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 0.8 mg/kg
n=3 participants at risk
OBI-999 0.8 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.2 mg/kg
n=6 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part A, Dose Escalation - OBI-999 1.6 mg/kg
n=3 participants at risk
OBI-999 1.6 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 1, Pancreatic
n=11 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 2, Colorectal Cancer
n=10 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
Part B, Cohort Expansion - Cohort 3, Basket (Any Other Solid Tumor Other Than Cohorts 1 and 2)
n=8 participants at risk
OBI-999 1.2 mg/kg was administered as an IV infusion on Day 1 of each 21-day cycle
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
36.4%
4/11 • Number of events 4 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 distension
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
30.0%
3/10 • Number of events 4 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
66.7%
2/3 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
100.0%
3/3 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
54.5%
6/11 • Number of events 10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
40.0%
4/10 • Number of events 7 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Chest pain
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
30.0%
3/10 • Number of events 5 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
AST increased
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
ALT increased
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 alkaline phosphatase increased
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Platelet count decreased
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Myalgia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 4 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
30.0%
3/10 • Number of events 4 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Muscle spasms
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
27.3%
3/11 • Number of events 6 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
30.0%
3/10 • Number of events 4 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Hyponatraemia
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Hypoalbuminaemia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
18.2%
2/11 • Number of events 5 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/10 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 2 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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
Neutropenia
|
0.00%
0/3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
66.7%
2/3 • Number of events 3 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
0.00%
0/11 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part 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 for up to approximately 2 years after first dose
Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total 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