Trial Outcomes & Findings for Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) (NCT NCT04203160)
NCT ID: NCT04203160
Last Updated: 2025-12-31
Results Overview
Dose limiting toxicities will determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of combination therapy with CPI-613 + gemcitabine and cisplatin. Assessed using the NCI CTCAE v5.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Up to day 22
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
Phase 2, Arm A (Investigational)
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
18
|
1
|
1
|
2
|
16
|
|
Overall Study
COMPLETED
|
19
|
6
|
0
|
1
|
2
|
10
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
1
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
Phase 2, Arm A (Investigational)
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Overall Study
Alternative Therapy
|
3
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
0
|
0
|
0
|
4
|
|
Overall Study
Adverse Event
|
7
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Termination
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Baseline characteristics by cohort
| Measure |
Phase 2, Arm A (Investigational)
n=37 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=18 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
n=1 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
n=1 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
n=2 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
n=16 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=1000 Participants
|
4 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=357 Participants
|
25 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=1000 Participants
|
14 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
10 Participants
n=357 Participants
|
50 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=1000 Participants
|
12 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=357 Participants
|
37 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=1000 Participants
|
6 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
10 Participants
n=357 Participants
|
38 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=1000 Participants
|
3 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=357 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
1 Participants
n=62 Participants
|
14 Participants
n=357 Participants
|
64 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=357 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=357 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
1 Participants
n=2008 Participants
|
1 Participants
n=4994 Participants
|
2 Participants
n=62 Participants
|
13 Participants
n=357 Participants
|
66 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=357 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=1000 Participants
|
18 participants
n=1986 Participants
|
1 participants
n=2008 Participants
|
1 participants
n=4994 Participants
|
2 participants
n=62 Participants
|
16 participants
n=357 Participants
|
75 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to day 22Population: only applies to Phase 1 patients
Dose limiting toxicities will determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of combination therapy with CPI-613 + gemcitabine and cisplatin. Assessed using the NCI CTCAE v5.0
Outcome measures
| Measure |
Phase 2, Arm A (Investigational)
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
n=1 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
n=1 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
n=2 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
n=16 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Phase 1: Incidence of Dose-limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Until last dose of study treatment (up to 2 years)Population: Phase 2, Arm A- 37 patients were randomized to Arm A treatment, with 36 patients receiving treatment. Per protocol the 16 patients in the Phase 1 portion of the study were included, for a total of 52 patients in the investigational arm. All 52 subjects were considered for evaluability. Two subjects were found to be unevaluable. Phase 2, Arm B- 18 patients were randomized to Arm B treatment, with 16 patients receiving treatment.Three subjects were found to be unevaluable.
Objective response assessment will be determined by review of CT or MR scans of the chest, abdomen and pelvis. ORR (Partial Response + Complete Response) will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, during active study treatment. All enrolled patients who receive at least 1 cycle of therapy and have their disease re-evaluated will be considered evaluable for response. (Note: Patients who exhibit objective disease progression prior to the end of cycle 1 will also be considered evaluable.)
Outcome measures
| Measure |
Phase 2, Arm A (Investigational)
n=50 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=13 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR)
|
15 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until last dose of study treatment (up to 2 years)Population: Phase 2, Arm A- 37 patients were randomized to Arm A treatment, with 36 patients receiving treatment. Per protocol the 16 patients in the Phase 1 portion of the study were included, for a total of 52 patients in the investigational arm. All 52 subjects were considered for evaluability. Two subjects were found to be unevaluable. Phase 2, Arm B- 18 patients were randomized to Arm B treatment, with 16 patients receiving treatment. Three subjects were found to be unevaluable.
PFS will be determined from date of first study treatment until the date of radiological or clinical progression (leading to withdrawal from the study) or date of last disease evaluation (for patients without progression). It will be calculated using the product-limit method of Kaplan and Meier. All patients that receive at least one dose of study treatment will be considered evaluable.
Outcome measures
| Measure |
Phase 2, Arm A (Investigational)
n=50 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=13 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
8.7 months
Interval 5.8 to 11.3
|
9.6 months
Interval 7.3 to
not yet estimable as trial was terminated by the sponsor
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years after enrollmentPopulation: Phase 2, Arm A- 37 patients were randomized to Arm A treatment, with 36 patients receiving treatment. Per protocol the 16 patients in the Phase 1 portion of the study were included, for a total of 52 patients in the investigational arm. All 52 subjects were considered for evaluability. Two subjects were found to be unevaluable. Phase 2, Arm B- 18 patients were randomized to Arm B treatment, with 16 patients receiving treatment. Three subjects were found to be unevaluable.
From date of first study treatment until date of last disease evaluation or until death from any cause. Using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Phase 2, Arm A (Investigational)
n=50 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=13 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
15.6 months
Interval 11.8 to 22.5
|
22.2 months
Interval 8.6 to
NA as not yet estimable as trial was terminated by the sponsor
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days after last dose of study treatmentPopulation: Phase 2, Arm A- 37 patients were randomized to Arm A treatment, with 36 patients receiving treatment. Per protocol the 16 patients receiving the RP2D of Devimistat in the Phase 1 portion of the study were included, for a total of 52 patients. This combination was done per protocol. Phase 2, Arm B- 18 patients were randomized to Arm B treatment, with 16 patients receiving treatment. For 16 receiving study treatment
To evaluate the safety of CPI-613 in combination with gemcitabine and cisplatin in this patient population, assessed using the Common Toxicity Criteria for Adverse Events (CTCAE) v5.0. All patients that receive at least one dose of study treatment will be considered evaluable. Number of patients experiencing the maximum graded toxicity (Grade 2 or higher).
Outcome measures
| Measure |
Phase 2, Arm A (Investigational)
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=52 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
n=16 Participants
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Incidence of Toxicities
Nausea- Grade 2
|
—
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Anorexia- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Anorexia- Grade 2
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Abdominal pain- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Alanine aminotransferase increased- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Alopecia- Grade 2
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Anemia- Grade 2
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Anemia- Grade 3
|
—
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Aspartate aminotransferase increased- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Bacteremia- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Biliary tract Infection- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Blood transfusion- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Blood bilirubin increased- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
chest tightness- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Cholecystitis- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Constipation- Grade 2
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Creatinine increased- Grade 2
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Diarrhea- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Diarrhea- Grade 3
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Dysgeusia- Grade 2
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Enterocolitis- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Fatigue- Grade 2
|
—
|
15 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Fatigue- Grade 3
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Febrile Neutropenia- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Flu like symptoms- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Gastroesophageal relux disease- Grade 2
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
hypersalivation- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
generalize muscle weakness- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hematuria- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hiccups- Grade 2
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hot flashes- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypercalcemia- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hyperglycemia- Grade 2
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypertension- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypertension- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypoalbuminemia- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypokalemia- Grade 2
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypomagnesemia- Grade 2
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypomagnesemia- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hyponatremia- Grade 3
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Infection- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Infusion Related Reaction- Grade 2
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Lymphocyte count decreased- Grade 3
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Neutrophil count decreased- Grade 2
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Neutrophil count decreased- Grade 3
|
—
|
18 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Neutrophil count decreased- Grade 4
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Pancreatitis- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Peripheral Motor Neuropathy- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Peripheral Sensory Neuropathy- Grade 2
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Platelet count decreased- Grade 2
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Platelet count decreased- Grade 3
|
—
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Platelet count decreased- Grade 4
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Sepsis- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Stroke- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Pulmonary Embolism- Grade 3
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Urinary Tract Infection- Grade 2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Vomiting- Grade 2
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
White Blood Cell Decreased- Grade 2
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
White Blood Cell Decreased- Grade 3
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Alanine aminotransferase increased- Grade 3
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Aspartate aminotransferase increased- Grade 3
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Fever- Grade 2
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Generalized Edema- Grade 2
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Liver Abscess- Grade 3
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Hypomagnesemia- Grade 4
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Incidence of Toxicities
Lymphocyte count decreased- Grade 4
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
Adverse Events
Phase 2, Arm A (Investigational)
Serious events: 13 serious events
Other events: 35 other events
Deaths: 25 deaths
Phase 2, Arm B (Standard of Care)
Serious events: 9 serious events
Other events: 15 other events
Deaths: 7 deaths
Phase 1, CPI-613 500 mg/m2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1, CPI-613 1000 mg/m2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1, CPI-613 1500 mg/m2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Phase 1, CPI-613 2000 mg/m2
Serious events: 11 serious events
Other events: 16 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Phase 2, Arm A (Investigational)
n=37 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=18 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
n=1 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
n=1 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
n=2 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
n=16 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Bile duct stenosis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Biliary tract infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Blood bilirubin increased
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Febrile neutropenia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Fever
|
2.7%
1/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Sepsis
|
16.2%
6/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Vertigo
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Anemia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Back pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Fall
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.7%
1/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
2.7%
1/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Hepatic infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Lower gastrointestinal hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Lung infection
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Neutrophil count decreased
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Nervous system disorders
Stroke
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Cholangitis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Progressive Disease
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
biliary obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Giardiasis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Pulmonary edema
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
Other adverse events
| Measure |
Phase 2, Arm A (Investigational)
n=37 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 2, Arm B (Standard of Care)
n=18 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 500 mg/m2
n=1 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1000 mg/m2
n=1 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 1500 mg/m2
n=2 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
Phase 1, CPI-613 2000 mg/m2
n=16 participants at risk
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
CPI 613: Given intravenously
Gemcitabine: Given intravenously
Cisplatin: Given intravenously
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
27.0%
10/37 • Number of events 20 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
33.3%
6/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
56.2%
9/16 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
8.1%
3/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Allergic reaction
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Alopecia
|
13.5%
5/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Anemia
|
32.4%
12/37 • Number of events 58 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
61.1%
11/18 • Number of events 25 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
8/16 • Number of events 24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Anorexia
|
24.3%
9/37 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
38.9%
7/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
31.2%
5/16 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Back pain
|
13.5%
5/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Bile duct stenosis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Biliary tract infection
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Blood bilirubin increased
|
5.4%
2/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
31.2%
5/16 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Eye disorders
Blurred vision
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Bone pain
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Breast pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Bruising
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Eye disorders
Cataract
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Chills
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Cholesterol high
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Confusion
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
40.5%
15/37 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
56.2%
9/16 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Creatinine increased
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Cystitis noninfective
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dehydration
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.9%
7/37 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
22.2%
4/18 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
62.5%
10/16 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dizziness
|
21.6%
8/37 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
33.3%
6/18 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Eye disorders
Dry eye
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dry mouth
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Duodenal obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dysesthesia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Dysgeusia
|
16.2%
6/37 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dyspepsia
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Dysphagia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Dysuria
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Edema limbs
|
13.5%
5/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
22.2%
4/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Enterocolitis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Epistaxis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Extrapyramidal disorder
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Fall
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Fatigue
|
67.6%
25/37 • Number of events 44 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
44.4%
8/18 • Number of events 12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
93.8%
15/16 • Number of events 24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Febrile neutropenia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Fever
|
8.1%
3/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Flank pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Eye disorders
Floaters
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Flu like symptoms
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Flushing
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Gastric hemorrhage
|
2.7%
1/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Generalized edema
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Generalized muscle weakness
|
13.5%
5/37 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Headache
|
10.8%
4/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hematoma
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
2.7%
1/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hemolytic uremic syndrome
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hemorrhoidal hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hemorrhoids
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Hepatic infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hiccups
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hoarseness
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hot flashes
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Hypercalcemia
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hyperglycemia
|
10.8%
4/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hyperhidrosis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hyperkalemia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Vascular disorders
Hypertension
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Hyperuricemia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hypoalbuminemia
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hypocalcemia
|
5.4%
2/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hypokalemia
|
13.5%
5/37 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hypomagnesemia
|
24.3%
9/37 • Number of events 21 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
22.2%
4/18 • Number of events 21 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Hyponatremia
|
8.1%
3/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Hypoxia
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Infusion related reaction
|
13.5%
5/37 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Psychiatric disorders
Insomnia
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Lower gastrointestinal hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Lung infection
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
8.1%
3/37 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Mucositis oral
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Muscle cramp
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Muscle weakness lower limb
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Myalgia
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
40.5%
15/37 • Number of events 24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
33.3%
6/18 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
68.8%
11/16 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Neck pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Nervous system disorders
Neuralgia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Neutrophil count decreased
|
40.5%
15/37 • Number of events 33 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
55.6%
10/18 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
62.5%
10/16 • Number of events 19 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Oral dysesthesia
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Osteoporosis
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Pain
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Pain in extremity
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Paresthesia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Pelvic pain
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
Platelet count decreased
|
27.0%
10/37 • Number of events 27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
27.8%
5/18 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
31.2%
5/16 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.2%
6/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
2/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
31.2%
5/16 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Peritoneal infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Pleural effusion
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Pneumonitis
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Portal hypertension
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Postnasal drip
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Presyncope
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Pulmonary edema
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.2%
6/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Rhinorrhea
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Sepsis
|
16.2%
6/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Small intestinal obstruction
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Sore throat
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Stomach pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Stroke
|
5.4%
2/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Syncope
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Thromboembolic event
|
10.8%
4/37 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Thrush
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
12.5%
2/16 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Tooth infection
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Toothache
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Cardiac disorders
Transient ischemic attacks
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Injury, poisoning and procedural complications
Upper gastrointestinal hemorrhage
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
5.4%
2/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
10.8%
4/37 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
18.8%
3/16 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Vascular access complication
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Vertigo
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
29.7%
11/37 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
100.0%
1/1 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
50.0%
1/2 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
37.5%
6/16 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Weight gain
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
General disorders
Weight loss
|
8.1%
3/37 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
6.2%
1/16 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
|
Investigations
White blood cell decreased
|
13.5%
5/37 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
5.6%
1/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
0.00%
0/2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
25.0%
4/16 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. All-Cause Mortality monitored/assessed up to 3 years
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60